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Article Title

Pharmacokinetic properties of tranilast in Chinese people

Abstract

The pharmacokinetics and relative bioavailability of two different formulated tranilast capsules were determined after single dosing in twelve healthy Chinese subjects in a two-way crossover study. Blood samples were obtained from predose until 24 h postdose. Plasma concentration of tranilast was determined by an HPLC method. Since no differences in pharmacokinetic parameters were found between the two distinctive tranilast products (Tranpro® and Rizaben®), the data were pooled together to characterize the pharmacokinetic property of tranilast. Mean peak plasma concentrations after dosing and the time at which it occurred (Tmax were 42.2 ± 5.92 μg/mL and 2.79 ± 1.14 h, respectively. The elimination half-life and total body plasma clearance were 7.5 8 ± 1.44 h and 8.12 ± 1.31 mL/h/kg, respectively. The respective areas under the concentration-time curve from time 0 to infinity for Tranpro® and Rizaben® were 431 ± 97 and 412 ± 60 μg-h/mL. The results also indicated that the two tranilast products can be considered as bioequivalent.

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