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Bioavailability Section

Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects 

Dan-Bee Park, Kyungho Jang, Jae-Won Lee, Cheol-Won Park, Back-Hwan Lee, Min-Gul Kim, and Ji-Young Jeon

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Volume 55 (2017) p. 286 - 294

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 3/2017 (286-294)

Dan-Bee Park¹*, Kyungho Jang¹,²*, Jae-Won Lee³, Cheol-Won Park³, Back-Hwan Lee³, Min-Gul Kim¹,⁴, and Ji-Young Jeon¹

¹Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Jeonju, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, ³Research & Development Division, Alvogen Korea CO., Ltd., and ⁴Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Republic of Korea
Context: A fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance. Objective: This study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers. Materials and Methods: A total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test formulation (FDC tablet containing candesartan and rosuvastatin) or reference formulation (co-administration of candesartan and rosuvastatin). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours post-dose. Safety and tolerability were assessed by the evaluation of adverse events (AEs), physical examinations, laboratory assessments, 12-lead electrocardiograms (ECGs), and vital sign measurements. Results: The 90% confidence intervals (CIs) of the geometric least-square mean ratios of C_max, AUC_last, and AUC_inf were 0.86 – 1.00, 0.92 – 1.04, and 0.92 – 1.03 for candesartan, and 0.88 – 1.06, 0.91 – 1.08, and 0.91 – 1.03 for rosuvastatin, respectively. All of the AEs were mild, and there was no significant difference in the incidence of AEs between the formulations. Furthermore, the pharmacokinetic properties of the test and reference formulations met the regulatory criteria for bioequivalence. Discussion and conclusion: Both formulations were safe and well tolerated, and no significant difference was observed in the safety assessments of the treatments. Correspondence to:
Ji-Young Jeon, PhD
Center for Clinical Pharmacology and Biomedical Research Institute
Chonbuk National University Hospital
20, Genji-ro, Deokjin-gu, Jeonju-si,
Jeollabuk-do 54907, Korea 
Email: [email protected]

Original Research

Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects 

Sang Won Lee, Yewon Choi, Kyungho Jang, Seo Hyun Yoon, and Jae-Yong Chung

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Volume 58 (2020) p. 634 - 641

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 58 – No. 11/2020 (634-641)

Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects 

Sang Won Lee¹, Yewon Choi², Kyungho Jang³, Seo Hyun Yoon¹, and Jae-Yong Chung⁴

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea, ²Genosco Inc., Cambridge, MA, USA, ³Center for Clinical Pharmacology, Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Jeonbuk, and ⁴Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam, Republic of Korea
Background: Amoxicillin/clavulanate is a widely used oral formulation of penicillin combined with a β-lactamase inhibitor. When using amoxicillin/clavulanate in the elderly, the risk of adverse drug reaction may be greater. This study aimed to evaluate the pharmacokinetics (PKs) and safety of multiple-dose amoxicillin/clavulanate administration in healthy elderly subjects and to compare the observed PK profiles with those in healthy younger adults. An open-label, one-sequence, multiple administration study was conducted in 16 healthy elderly subjects.
Materials and methods: Subjects orally received amoxicillin and clavulanate 750/187.5 twice daily for 9 days. For PK analysis, serial blood samples were collected up to 12 hours after the last administration of amoxicillin/clavulanate. The demographic and PK data of this study were compared to those of healthy young adults from a separate study with a similar design. Safety assessments including clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring were performed throughout the study.
Results: All AEs were mild, and no serious AEs were reported in this study. The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects. However, the time required to reach maximum concentration at steady state and the elimination half-life were similar in the two age groups.
Conclusion: Although multiple administration of amoxicillin/clavulanate 750/187.5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects.Correspondence to:
Jae-Yong Chung, MD, PhD 
Department of Clinical Pharmacology and Therapeutics
Seoul National University College of Medicine  and Bundang Hospital
Seongnam, Republic  of Korea
Email: [email protected]

Bioavailability Section

Pharmacokinetics and bioequivalence of tofacitinib 5 mg in healthy Korean male subjects 

Ji-hyoung Lee, Ji-Young Jeon, Kyungho Jang, Sung Kwon Kang, Yong-Geun Kwak, Seol Ju Moon, and Min-Gul Kim

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Volume 62 (2024) p. 142 - 148

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 3/2024 (142-148)

Pharmacokinetics and bioequivalence of tofacitinib 5 mg in healthy Korean male subjects 

Ji-hyoung Lee¹, Ji-Young Jeon², Kyungho Jang³, Sung Kwon Kang⁴, Yong-Geun Kwak¹#², Seol Ju Moon¹#²#⁵, and Min-Gul Kim¹#²#⁵

¹Department of Pharmacology, School of Medicine, ²Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, ³Department of Clinical Development, Cha Biotech, Seongnam, ⁴Department of Synthetic Chemistry, Chong Kun Dang Research Institute, Yongin, and ⁵Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, Republic of Korea
Objective: Tofacitinib is an oral Janus kinase (JAK) inhibitor marketed as an immunomodulator that can effectively treat rheumatoid arthritis. This study aimed to compare the pharmacokinetics and evaluate the bioequivalence of tofacitinib free base (CKD-374) with those of tofacitinib citrate (Xeljanz).
Materials and methods: A randomized, open-label, single-dose, 2-sequence, 2-period crossover study was conducted in healthy Korean male subjects. A total of 36 subjects were randomized into two sequence groups. At each period, subjects were administered the test formulation (tofacitinib free base, 5 mg) or the reference formulation (tofacitinib citrate, 8.078 mg; as tofacitinib, 5 mg). The plasma samples were collected up to 12 hours post dose and analyzed by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters, including maximum plasma concentration (C_max) and area under the plasma concentration vs. time curve from dosing to the last measurable concentration (AUC_0–t), were determined by non-compartmental analysis. The 90% confidence intervals (CIs) of the geometric mean ratios for C_max and AUC_0–t were calculated to evaluate pharmacokinetic equivalence.
Results: The 90% CIs of the geometric mean ratios of C_max and AUC_0–t for tofacitinib free base to tofacitinib citrate were 0.9144 – 1.1230 and 1.0245 – 1.0932, respectively. All reported adverse events were of mild intensity, and there were no serious adverse events.
Conclusion: In healthy Korean male adult subjects, the pharmacokinetic parameters of tofacitinib free base and tofacitinib citrate were evaluated and met the pharmacokinetic bioequivalent criteria. Both formulations were safe and well-tolerated. 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-si,
Jeollabuk-do, 54907, Republic of Korea
Email: [email protected]

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