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Bioavailability Section

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

Sumin Yoon, SeungHwan Lee, Kyung-Sang Yu, Sung-Vin Yim, Bo-Hyung Kim

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Volume 55 (2017) p. 194 - 200

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]

Bioavailability Section

Pharmacokinetic comparison using two tablets of an evogliptin/metformin XR 2.5/500 mg fixed dose combination vs. 1 tablet each of evogliptin 5 mg and metformin XR 1,000 mg 

Sumin Yoon, Su-jin Rhee, Sang-In Park, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, SeungHwan Lee, Kyung-Sang Yu

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42.00 $

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42.00 $

Volume 55 (2017) p. 533 - 539

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 6/2017 (533-539)

Pharmacokinetic comparison using two tablets of an evogliptin/metformin XR 2.5/500 mg fixed dose combination vs. 1 tablet each of evogliptin 5 mg and metformin XR 1,000 mg 

Sumin Yoon¹, Su-jin Rhee¹, Sang-In Park¹, Seo Hyun Yoon¹, Joo-Youn Cho¹, In-Jin Jang¹, SeungHwan Lee¹,², Kyung-Sang Yu¹ 

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, and ²Clinical Trials Center, Seoul National University Biomedical Research Institute, Seoul, Republic of Korea
Objectives: The aim of this study was to compare the pharmacokinetic (PK) characteristics of evogliptin and metformin following the administration of 2 evogliptin/metformin extended-release (XR) 2.5/500 mg FDC tablets with the coadministration of separate evogliptin 5-mg and metformin XR 1,000-mg tablets (separate formulations). Methods: A randomized, two-period, two-sequence crossover study was conducted. Subjects were randomly assigned to receive 2 FDC tablets or the individual tablets, followed by a 14-day washout period and the administration of the alternate treatment. Blood samples were collected predose and up to 72 hours postdose for each period. PK parameters including C_max and AUC_last were calculated. The geometric mean ratios (GMRs) and the 90% confidence intervals (CIs) between FDC and the separate formulations were calculated for the C_max and AUC_last of evogliptin and metformin. Results: 33 subjects completed the study. The GMR (90% CI) values of C_max and AUC_last for evogliptin were 1.011 (0.959 – 1.066) and 1.010 (0.977 – 1.043), respectively. The GMR (90% CI) values of C_max and AUC_last for metformin were 0.892 (0.827 – 0.963) and 0.893 (0.841 – 0.947), respectively. There was no significant difference between the FDC and separate formulations regarding the occurrence of adverse events. All drug-related adverse events were considered to be mild and resolved without any treatment. Conclusions: Two FDC tablets of evogliptin/metformin XR 2.5/500 mg showed a similar PK profile to the separate formulations of evogliptin 5 mg and metformin XR 1,000 mg. All of the 90% CIs of GMR satisfied the regulatory bioequivalence criteria of 0.800 – 1.250. 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, Republic of Korea 
Email: [email protected]

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