Abstract

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.


Author Details

Authors

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

Departments

• ¹ Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University,
• ² Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, College of Medicine and Hospital,
• ³ Department of Clinical Pharmacology and Therapeutics, and
• ⁴ East-West Medical Research Institute, Kyung Hee University College of Medicine and Hospital, Seoul, Korea

Address

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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