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Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 2/2012 (142-149)

Pharmacokinetics of a fixed-dose glimepiride/sustained-release metformin combination

Kyu-pyo Kim¹*, Kyoung Soo Lim*, Bo-Hyung Kim, Hyun-Suk Shin, Joo-Youn Cho, Sang-Goo Shin, In-Jin Jang and Kyung-Sang Yu

Department of Pharmacology and Clinical Pharmacology, Seoul National University College of Medicine and Hospital, Seoul, Korea

*Both authors contributed equally to this work.
¹Current affiliation: Department of Internal Medicine, Ulsan University College of Medicine and Asan Medical Center, Seoul, Korea
Objective: Pharmacokinetic (PK) profiles of glimepiride and metformin have been established for the combination drug as well as each agent individually. However, the PK profiles of a combination drug containing glimepiride and sustainedrelease (SR) metformin have not been reported. To compare the pharmacokinetic profiles of glimepiride/SR metformin (2 mg/500 mg) with the PK of immediate-release (IR) formulations, an open-label, randomized, 3-period, 3-sequence, 3-treatment, crossover study was conducted in 12 healthy subjects. Methods: After a single administration of glimepiride/SR metformin 2 mg/500 mg (Treatment) or glimepiride/metformin IR 2 mg/500 mg (Reference 1), or administration of 2 doses of glimepiride/metformin IR 1 mg/250 mg 12 h apart (Reference 2), serial blood samples were collected and drug concentrations determined by liquid chromatography/ tandem mass spectrometry. PK parameters (C_max and AUC₂₄) for glimepiride and metformin were log-transformed and compared using a mixed-effects model analysis of variance (ANOVA). The mean differences and 95% confidence intervals (CIs) were back-transformed to obtain geometric mean ratios along with the CIs for the ratios. Results: Treatment demonstrated similar systemic exposures for glimepiride; the geometric mean ratio (95% CIs) for glimepiride AUC₂₄ was 1.05 (0.97 – 1.13) for Treatment relative to Reference 1 and 1.08 (1.00 – 1.17) for Treatment relative to Reference 2. The SR formulation showed a delay in the time to reach maximum concentration for metformin from 1.0 – 4.0 h to 4.0 – 8.0 h and a decreased AUC₂₄ value; the geometric mean ratio for metformin AUC₂₄ was 0.87 (0.74 – 1.03) for Treatment relative to Reference 1 and 0.75 (0.63 – 0.88) for Treatment relative to Reference 2. Conclusions: This study demonstrates for the first time that fixed-dose glimepiride and SR metformin 2 mg/500 mg shows a PK profile similar to that of glimepiride, but with a delayed time to maximum concentration and slightly decreased bioavailability for metformin compared with the IR fixed-dose combination, in healthy volunteers. PK profiles from this exploratory study will be helpful in designing and conducting further studies in diabetic patients.Correspondence to:
Kyung-Sang Yu, MD, PhD
Department of Pharmacology and Clinical Pharmacology
National University College of Medicine and Hospital
101 Daehangno, Jongno-gu, Seoul 110-744, Korea
Email: [email protected]

Abstract

Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase IV inhibitor LC15-0444 and pioglitazone in healthy volunteers

Sung Eun Kim¹, SoJeong Yi¹, Kwang-Hee Shin¹, Tae-Eun Kim¹, Min-Jeong Kim², Youn Hoa Kim³, Seo Hyun Yoon¹, Joo-Youn Cho¹, Sang-Goo Shin¹, In-Jin Jang¹ and Kyung-Sang Yu¹

¹Department of Pharmacology and Clinical Pharmacology, Seoul National University College of Medicine and Hospital, ²Department of Clinical Development and ³Department of DMPK, LG Life Sciences, Ltd, Seoul, Republic of Korea
Objective: LC15-0444, a newly developed selective dipeptidyl peptidase IV inhibitor, has the potential to be administered with other antihyperglycemic agents. The aim of this study was to investigate the interaction between LC15-0444 and pioglitazone by comparing the pharmacokinetics of both compounds and their metabolites. Methods: A randomized, open-label, multiple dosing, three-sequence, three-period, three-treatment crossover study was performed in healthy volunteers. The three treatment groups were comprised of LC15-0444 200 mg, pioglitazone 30 mg, or coadministration of both drugs once daily for 12 days. Blood samples were collected up to 48 hours after the last dosing. Safety and tolerability were assessed throughout the study. Results: The geometric mean ratios (GMRs; (LC15-0444+Pioglitazone coadministered)/(LC15-0444 or Pioglitazone alone)) (90% confidence intervals (CIs)) for C_max,ss and AUC_t,ss of LC15-0444 were 1.06 (0.96 – 1.16) and 0.98 (0.93 – 1.03), respectively. In the case of pioglitazone, the GMRs (90% CIs) for C_max,ss and AUC_t,ss were 0.84 (0.73 – 0.96) and 0.85 (0.76 – 0.96), respectively. All reported adverse events were mild in intensity. Conclusions: The pharmacokinetics of LC15-0444 and its metabolites were not altered by pioglitazone. The systemic exposure of pioglitazone was decreased by 15% after coadministration of LC15-0444 with pioglitazone, but this was not judged to be clinically relevant, considering the total active moiety of pioglitazone.Correspondence to:
K.-S. Yu, MD, PhD
Department of Pharmacology and Clinical Pharmacology
Seoul National University
College of Medicine and Hospital
101 Daehak-ro, Jongno-gu,
Seoul 110-744, Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 3/2012 (224-232)

A positron emission tomography microdosing study with sertraline in healthy volunteers

Kwang-Hee Shin¹, Kyu-pyo Kim¹, Kyoung Soo Lim¹, Ji Who Kim², Yun-Sang Lee², Bo Yeun Yang², Jae Sung Lee², Jae-Min Jung², Seo-Hyun Yoon¹, In-Jin Jang¹ and Kyung-Sang Yu¹

¹Department of Pharmacology and Clinical Pharmacology, Seoul National University College of Medicine and Hospital, and ²Department of Nuclear Medicine, Seoul National University College of Medicine and Hospital, Seoul, Korea
Objective: This study explored microdosing methods for evaluating the distribution and pharmacokinetics (PK) of a central nervous system (CNS) drug candidate. Methods: We used sertraline as a model drug. In this open-label, one-arm, three-period, multiple-dosing study, 10 healthy male volunteers received 6-day administrations of sertraline at doses of 5, 25 or 50 mg/d in three different periods. Before the first dose of Period 1, and 24 h after the last dose of each period, an intravenous bolus of [¹¹C]sertraline was injected for positron emission tomography (PET) scanning. After the sixth dose in each period, serial blood samples were collected at scheduled intervals over 48 h; then serum sertraline concentrations were determined with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Results: Sertraline was distributed in the brain within 20 min, and it was highly distributed in the putamen, cingulate, and thalamus. Linearity in steady-state C_max and AUC_last were observed in the 5 – 50 mg dose range. The results suggested that microdosing with PET was a useful method for exploring the bloodbrain- barrier penetration and distribution of a candidate CNS drug. Conclusions: This study described a microdosing method that combined PET with LC-MS/MS for determining the brain distribution and PK characteristics of a CNS drug candidate.Correspondence to:
Kyung-Sang Yu, MD, PhD
Assistant Professor of Clinical Pharmacology
College of Medicine
Seoul National University Clinical Trials
Center Seoul National University Hospital
101 Daehangno, Jongno-gu,
Seoul, 110-744 Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 10/2012 (722-728)

Multiple-dose pharmacokinetics of fesoterodine sustained-release in healthy Korean volunteers

Dongseong Shin, Kwang-Hee Shin, SeungHwan Lee, Kyoung Soo Lim, Joo-Youn Cho, In-Jin Jang, Sang-Goo Shin and Kyung-Sang Yu

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea
Objective: Fesoterodine is a pro-drug of the active metabolite 5-hydroxymethyl tolterodine (5-HMT), a muscarinic receptor antagonist. This study aimed to evaluate the safety profile and pharmacokinetic characteristics of multiple oral doses of sustained-release fesoterodine (fesoterodine SR) in healthy Korean males. Methods: A randomized, double-blind, placebo-controlled, multiple-dose study with two oral doses (4 mg and 8 mg) was conducted in healthy Korean male participants. The study drug was administered once daily for 5 days. The plasma concentration of 5-HMT was measured up to 72 hours after the last drug administration. The CYP2D6 genotype was analyzed using polymerase chain reaction (PCR) methods to assess the effect of genetic polymorphisms on the pharmacokinetic parameters. Results: 20 participants completed the study. The mean (SD) areas under the plasma concentration-time curves during the dosing interval (AUC_τ) of the 4 mg and 8 mg dose groups were 26.1 (8.0) and 64.2 (30.5) μg∙h/ml and the mean peak concentrations (C_max) were 2.6 (0.7) and 6.0 (2.0) μg/ml, respectively, at steady-state. The mean AUC_τ and C_max of 5-HMT increased in approximately the same proportion as the dose increased. Fesoterodine SR was well tolerated without any serious adverse events or abnormal clinical laboratory findings. Conclusion: Systemic 5-HMT exposure showed dose-proportional characteristics in the 4 mg to 8 mg dose range in healthy Korean males. Thus, 4 mg or 8 mg doses of fesoterodine SR taken once-daily were tolerable in healthy Korean males.Correspondence to:
Kyung-Sang Yu, MD, PhD
Department of Clinical Pharmacology and Therapeutics Seoul
National University College of Medicine and Hospital Seoul
101 Daehangno, Jongno-gu
Seoul 110-744, Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 10/2013 (780-786)

Usefulness of oral loading of oxcarbazepine suspension in selected patients with epilepsy

Dong Wook Kim¹, Namyi Gu², Howard Lee², In-Jin Jang², Kon Chu³, Kyung-Sang Yu², Joo-Youn Cho², Seo Hyun Yoon², Hyun Jeong Na² and Sang Kun Lee³

¹Department of Neurology, Konkuk University School of Medicine, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, and ³Department of Neurology, College of Medicine, Seoul National University Hospital, Seoul, Korea
Objectives: Oral loading of oxcarbazepine tablet is effective and well tolerated to adequately achieve the therapeutic levels of its active metabolite, 10,11-dihydro-10-hydroxy-carbazepine (monohydroxy derivative, MHD) in epilepsy patients. The present study was performed to investigate the safety, tolerability, and pharmacokinetic profiles of oral loading of oxcarbazepine suspension in epilepsy patients with a high risk of recurrent seizures. Methods: Oxcarbazepine suspension was administered orally at a single loading dose of 30 mg/kg to 38 adult patients with recurrent seizures, who required rapid seizure control or temporarily discontinued antiepileptic drugs for diagnostic or pre-surgical evaluation. Plasma concentrations of oxcarbazepine and MHD were determined, and adverse events were assessed at 2, 4, 6, 8, 10, 12, 14, 16, and 24 hours after oral loading of oxcarbazepine suspension. Results: 30 patients experienced ≥ 1 adverse event during the first 24 hours after oral loading of oxcarbazepine (e.g., dizziness, transient diplopia, nausea or vomiting), most of which occurred within 4 hours after loading, suggesting no temporal association with MHD plasma levels. 35 (92.1%) patients were still compliant with a maintenance dose of oxcarbazepine after discharge from hospital. 34 (89.4%) patients reached the lower therapeutic level of MHD (12 mg/l) at 4 hours after oral loading of oxcarbazepine suspension, which lasted up to 24 hours in most patients. No patient reached the supratherapeutic levels of MHD (> 35 mg/l) during the study. The mean plasma concentration-time curves and pharmacokinetic profiles of oral loading of oxcarbazepine suspension were similar to those of oral loading of oxcarbazepine tablet. Conclusions: Oral loading of oxcarbazepine suspension followed by maintenance dosing is well tolerated and effective in steadily achieving the therapeutic level of MHD in selected patients with epilepsy.Correspondence to:
Sang Kun Lee, MD, PhD, Department of Neurology, Seoul National University Hospital, 28, Yongkeun dong, Chongno Ku, Seoul, 110-744, Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 11/2016 (928-934)

A bioequivalence study of two omeprazole formulations in healthy male volunteers

Yu Kyong Kim¹, Seonghae Yoon¹, Kyung-Sang Yu¹, Bo-Hyung Kim², and Sung-Vin Yim²

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, and ²Department of Clinical Pharmacology and Therapeutics, Kyung Hee University College of Medicine and Hospital, Seoul, Korea
Objective: This study had a single-dose, randomized, open-label, 2-period, and 2-sequence crossover design to evaluate pharmacokinetic (PK) bioequivalence between the test and reference formulations. Methods and materials: Of the 34 healthy male volunteers enrolled, 4 were excluded owing to consent withdrawal before drug administration and the remaining 30 subjects were administered 20 mg each of the test and reference formulations of omeprazole. The blood samples for PK analysis were collected at the scheduled time-points, prior to dosing to 10 hours after dosing. Plasma concentrations of omeprazole were quantified by a liquid chromatography-tandem mass spectrometry method. Bioequivalence was assessed according to current guidelines issued by regulatory authorities. Results: The plasma concentration-time profiles of omeprazole were similar between the reference and test drugs. The geometric mean ratios (90% confidence interval: CI) of test to reference were 0.9104 (0.8538 – 0.9708) for peak plasma concentration (C_max) and 0.9304 (0.8836 – 0.9796) for area under the plasma concentration-time curve from time zero to time of last measureable concentration (AUC_0–t). Conclusion: The results from the PK analysis suggested that the reference and test formulations of 20 mg omeprazole capsules were bioequivalent in healthy male subjects.Correspondence to:
Sung-Vin Yim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Kyung Hee University College of Medicine and Hospital
23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 2/2017 (194-200)

The pharmacokinetic comparison and bioequivalence evaluation of two 10-mg baclofen formulations in healthy male subjects 

Sumin Yoon¹, SeungHwan Lee¹, Kyung-Sang Yu¹, Sung-Vin Yim², Bo-Hyung Kim²#³ 

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, ²Department of Clinical Pharmacology and Therapeutics, and ³East-West Medical Research Institute, Kyung Hee University College of Medicine and Hospital, Seoul, Korea
Backgrounds: Baclofen is used as a skeletal muscle relaxant for multiple sclerosis patients. It depresses the transmission of monosynaptic and polysynaptic reflex by stimulating GABA_β (gamma-aminobutyric acid) receptors. Objectives: The aim of this study was to compare the pharmacokinetic characteristics of two 10-mg baclofen formulations and to assess bioequivalence. Methods: A randomized, single-dose, two-period, two-sequence crossover study was conducted in healthy male subjects. Each subject received the test or reference formulations. After washout period, all subjects received the alternative formulation. Blood samples were collected for up to 24 hours after the dose in each period. Pharmacokinetic (PK) parameters, including t_max, C_max, and AUC_last were calculated by noncompartmental methods. The geometric mean ratio (GMR) of the test to the reference formulation and its 90% confidence interval (CI) for C_max and AUC_last were calculated for assessment of bioequivalence. Results: A total of 22 subjects completed the study. The median t_max of the test and the reference formulation were 1.50 and 1.25 hours, respectively. The mean (± SD) C_max of the test and the reference formulation were 141.401 ± 29.447 ng/mL and 138.837 ± 31.392 ng/mL, respectively. The mean (± SD) AUC_last of the two formulations were 702.404 ± 82.149 ng×h/mL and 726.803 ± 90.638 ng×h/mL, respectively. The GMR (90% CI) of the test to the reference formulation for the C_max and AUC_last were 1.0306 (0.9564 – 1.1106) and 0.9674 (0.9437 – 0.9916), respectively. Conclusions: The two different baclofen 10-mg formulations had similar PK profiles and were bioequivalent based on C_max and AUC_last. Correspondence to:
Bo-Hyung Kim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Kyung Hee University College of Medicine and Hospital
23 Kyungheedae-ro, Dongdaemun-gu,
Seoul 02447, Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 2/2019 (117-124)

Pharmacokinetic comparison of gemigliptin 50 mg and metformin 500 mg as a fixed-dose combination and loose combination 

Sang Won Lee¹, Sang-In Park¹, SeungHwan Lee¹, Jae-Yong Chung², and Kyung-Sang Yu¹

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam, Korea
Background: Metformin and dipeptidyl peptidase-4 (DPP-IV) inhibitors are commonly combined to treat patients with diabetes mellitus (DM). A new fixed-dose combination (FDC) drug containing gemigliptin, a DPP-IV inhibitor, and sustained-release metformin has been developed. This study aimed to compare the PKs and tolerability of FDC versus loose combination of gemigliptin 50 mg and metformin 500 mg. Materials and methods: A randomized, open-label, two-treatment, two-period, two-sequence, crossover study was conducted in 28 healthy subjects, who received a single oral dose of an FDC tablet of gemigliptin (50 mg) and sustained-release metformin (500 mg) or were coadministered gemigliptin (50 mg) and extended-release metformin (500 mg) with a 1-week washout. Serial blood samples were collected up to 48 hours after study drug administration, and the plasma concentrations of gemigliptin, LC15-0636 (active metabolite of gemigliptin), and metformin were determined using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using a noncompartmental method. Safety and tolerability were evaluated based on vital signs, adverse events, clinical laboratory tests, and electrocardiography. Results: The concentration-time profiles of gemigliptin and metformin were similar when they were administered as FDC or were coadministered. The geometric mean ratio (GMR) and its 90% CIs of Cmax for gemigliptin, LC15-0636, and metformin were 0.93 (0.85 – 1.02), 1.00 (0.94 – 1.06), and 1.03 (0.98 – 1.09), respectively. The corresponding values of AUClast were 0.97 (0.93 – 1.01), 1.00 (0.97 – 1.04), and 1.00 (0.95 – 1.05), respectively. There were no clinically meaningful differences in safety and tolerability. Conclusion: When comparing the AUClast and Cmax of gemigliptin, LC15-0636, and metformin, the 90% CIs were all within the range of 0.8 – 1.25, which is the commonly accepted range for evaluating bioequivalence.Correspondence to:
Kyung-Sang Yu, MD, PhD 
Department of Clinical Pharmacology and Therapeutics
Seoul National University College of Medicine and Hospital
101 Daehak-ro, Jongno-gu, Seoul, 03080, Korea 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 58 – No. 6/2020 (354-362)

Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects 

Seol Ju Moon¹#², Kyung-Sang Yu², Jina Jung³, Yong-il Kim³, and Min-Gul Kim¹#⁴#⁵

¹Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Deokjin-gu, Jeonju, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, ³Hanmi Pharmaceutical Co., Seoul, ⁴Research Institute of Clinical Medicine of Jeonbuk National University, and ⁵Department of Pharmacology, School of Medicine, Jeonbuk National University, Deokjin-gu, Jeonju, Republic of Korea
Objective: Asthma patients often have co-existing symptoms of allergic rhinitis and are often prescribed with both asthma and rhinitis treatments such as montelukast and levocetirizine. The objective of this study was to compare the pharmacokinetic profiles of a montelukast/levocetirizine fixed-dose combination chewable tablet with individual administration of montelukast and levocetirizine in healthy subjects.
Materials and methods: A randomized, open-label, single-dose crossover study was conducted in healthy male subjects. One of the following treatments was administered in each period: co-administration of 1 chewable tablet of montelukast 5 mg and 1 tablet of levocetirizine 5 mg or administration of 1 chewable tablet of montelukast/levocetirizine 5/5 mg fixed-dose combination. Serial blood samples were collected up to 48 hours post dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry. Pharmacokinetic parameters, including maximum plasma concentration (C_max) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUC_last), were determined by non-compartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% confidence intervals (CIs) of C_max and AUC_last were calculated to evaluate pharmacokinetic equivalence.
Results: A total of 22 subjects were included in pharmacokinetic analysis. The GLSM ratios and 90% CIs of C_max and AUC_last were 1.0054 (0.9535 – 1.0601) and 1.0628 (1.0013 – 1.1281) for montelukast and 1.0105 (0.9488 – 1.0764) and 1.0396 (0.9935 – 1.0879) for levocetirizine, respectively.
Conclusion: The pharmacokinetic parameters of montelukast and levocetirizine when administered as separate tablets or as a fixed-dose combination were compared, and the parameters met the pharmacokinetic equivalence criteria. (ClinicalTrials.gov Identifier: NCT03371849). Correspondence to:
Min-Gul Kim, MD, PhD
Center for Clinical Pharmacology and Biomedical Research Institute
Jeonbuk National University Hospital
20 Geonji-ro, Deokjin-gu, Jeonju, Republic of Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 6/2021 (478-484)

Pharmacokinetic comparison between tablet of varenicline tartrate and orally disintegrating film of varenicline salicylate in healthy subjects 

Eunwoo Kim¹, Jun Gi Hwang¹#², Su Jun Park³, Ji Young Han³, Young-Sim Choi², Se-Rin Park², Kyung-Sang Yu¹, Min Kyu Park², and SeungHwan Lee¹#⁴

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, ²Department of Clinical Pharmacology and Therapeutics, Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, ³CTCBIO Inc., Ansan-si, Gyeonggi-do, and ⁴Clinical Trials Center, Seoul National University Hospital, Seoul, Republic of Korea
Objective: Varenicline is an efficacious aid for smoking cessation. In this study, the pharmacokinetics and safety were compared between film-coated tablets of varenicline tartrate (reference drug) and the newly developed orally disintegrating films of varenicline salicylate (test drug), both of them contained 1 mg of varenicline.
Materials and methods: A randomized, open-label, single-dose, two-sequence, two-period crossover study was conducted in healthy male subjects. Serial blood samples were obtained for up to 72 hours in each period, with a washout period of 7 days or more. The pharmacokinetic parameters were calculated using the noncompartmental method. Safety profiles were assessed throughout the study.
Results: A total of 28 subjects completed the study. The plasma varenicline concentration-time profiles were similar for the two study drugs. The maximum plasma varenicline concentration (C_max) was 5,768.95 ng/L (mean) and 5,780.55 ng/L for the test drug and reference drug, respectively. The areas under the concentration-time curve from time 0 to the last measurable time point (AUC_0–t) were 94,086.30 h×ng/L and 89,958.55 h×ng/L for the test drug and reference drug, respectively. The geometric mean ratios (90% confidence intervals) of the test drug to the reference drug for C_max and AUC_0–t were 0.9955 (0.9488 – 1.0444) and 1.0449 (0.9848 – 1.1088), respectively, which fell within the bioequivalence range of 0.8 – 1.25. There was no difference in safety between the study drugs.
Conclusion: The pharmacokinetics and safety profiles were similar between the two study drugs. The orally disintegrating film of varenicline salicylate can be an alternative to varenicline tartrate tablets.Correspondence to:
SeungHwan Lee,  MD, PhD
Department of Clinical Pharmacology and Therapeutics
Seoul National University College of Medicine and Hospital
101 Daehak-ro, Jongno-gu,
Seoul 03080,  Republic of Korea
Email: [email protected]

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