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Pharmacokinetic Comparison of Two Formulations of Talniflumate 370 Mg Tablets in Healthy Korean Volunteers

Pharmacokinetic Comparison of Two Formulations of Talniflumate 370 Mg Tablets in Healthy Korean Volunteers

Yun Kim, Sung- Yim, Bo-Hyung Kim, SeungHwan Lee

Int J Clin Pharmacol Ther. 2017 Jan;55(1):102-108.

PMID: 27879193

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 (Cmax) and area under the concentration-time curve from zero to the time point with the last measurable concentration (AUClast) 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 Cmax and -AUClast 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. .

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP66898622	Talniflumate		66898-62-2	Price

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