Abstract

Background: Talniflumate, a prodrug of niflumic acid, is a potent analgesic and anti-inflammatory drug that has been widely used for the treatment of rheumatoid diseases. Objective: The aim of this study was to compare the pharmacokinetics and to evaluate the bioequivalence of two formulations of talniflumate 370 mg tablets (test formulation: Flumagen^® 370 mg tablet; reference formulation: Somalgen^® 370 mg tablet). Methods: A randomized, open-label, single dose, two-sequence, two-period crossover clinical study was conducted. After oral administration of the study drug in each period, blood samples were collected up to 15 hours post-dose. The plasma concentration of niflumic acid, a metabolite of talniflumate, was determined using HPLC-MS/MS. The pharmacokinetic parameters were estimated by non-compartmental method. Results: The maximum plasma concentration (C_max) and area under the concentration-time curve from zero to the time point with the last measurable concentration (AUC_last) for the test formulation were 290.7 ± 199 µg/L and 1,154 ± 643 µg×h/L, respectively, and the corresponding values for the reference formulation were 286.8 ± 193 µg/L and 1,151 ± 577 µg×h/L, respectively. The geometric mean ratio and 90% confidence intervals (CI) of the test formulation to the reference formulation for the C_max and ­AUC_last were 0.983 (0.829 – 1.166) and 0.979 (0.856 – 1.121), respectively. Conclusions: The pharmacokinetic profiles of the test and reference formulations were found not to be significantly different, meeting the Korean regulatory criteria for bioequivalence.


Author Details

Authors

• Yun Kim^{1, 2}
• Sung- Yim³
• Bo-Hyung Kim^{3, 4}
• SeungHwan Lee²


Departments

• ¹ Program in Biomedical Radiation Sciences, Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Suwon,
• ² Department of Clinical Pharmacology and Therapeutics, Seoul National University, 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
College of Medicine and Hospital
Daehak-ro, Jongno-gu, Seoul, 03080, Korea

Email: [email protected]

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