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Bioavailability Section

Comparative pharmacokinetic and bioequivalence evaluation of two formulations of morniflumate 350-mg tablets in healthy male subjects 

Heechan Lee, Sung-Vin Yim, Bo-Hyung Kim, SeungHwan Lee

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Volume 55 (2017) p. 95 - 101

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 1/2017 (95-101)

Comparative pharmacokinetic and bioequivalence evaluation of two formulations of morniflumate 350-mg tablets in healthy male subjects 

Heechan Lee¹,², Sung-Vin Yim³, Bo-Hyung Kim³,⁴, SeungHwan Lee²

¹Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, College of Medicine and Hospital, ³Department of Clinical Pharmacology and Therapeutics, and ⁴East-West Medical Research Institute, Kyung Hee University College of Medicine and Hospital, Seoul, Korea
Background: Morniflumate is a nonsteroid anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-1, 2 (COX-1, 2). Objective: This study aimed to compare the pharmacokinetics (PKs) and assess the bioequivalence of two different formulations of morniflumate 350-mg tablets in healthy Korean male subjects. Methods: A randomized, single-dose, two-period, two-sequence crossover study was conducted with 38 subjects. Subjects received a single dose of two tablets of either a test or a reference formulation and the alternated formulation in the next period. Serial blood samples for the PK analysis were collected over 12 hours. PK parameters were determined by a noncompartment analysis. PK parameters, including the maximum concentration (C_max) and the area under-the-concentration-time curve from time zero to the time of the last quantifiable concentration (AUC_last) were compared in bioequivalence tests. Results: The C_max of the test and reference formulations were 985.72 ± 6.80 mg/L and 947.09 ± 6.73 mg/L, respectively, while the AUC_last values were 2675.92 ± 7.84 mg×h/L and 2653.06 ± 7.78 mg×h/L, respectively. The geometric mean ratios (90% confidence interval) of the test formulation to the reference formulation for C_max and AUC_last were 1.0715 (0.9469 – 1.2124) and 1.0592 (0.9592 – 1.1695), respectively. Conclusions: The new formulation of morniflumate 350-mg tablet showed a PK profile similar to that of the marketed formulation, and the results of this study fell within in the conventional criteria of bioequivalence. Correspondence to:
SeungHwan Lee, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Seoul National University Hospital and College of Medicine
Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea 
Email: [email protected]

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