Pharmacokinetic properties of tranilast in Chinese people

Authors

M.-J. Charng
P.Y.-A. Ding
M.-H. Chuang
C.-Y. Lo
P.-S. Chiang
L.-H. Pao

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.

Recommended Citation

Charng, M.-J.; Ding, P.Y.-A.; Chuang, M.-H.; Lo, C.-Y.; Chiang, P.-S.; and Pao, L.-H. (2002) "Pharmacokinetic properties of tranilast in Chinese people," Journal of Food and Drug Analysis: Vol. 10 : Iss. 3 , Article 6.
Available at: https://doi.org/10.38212/2224-6614.2751

Fulltext URL

http://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f636698072701429928