Pharmacokinetic Properties of Tranilast in Chinese People
MIN-JI CHARNG 1, PHILIP YU-AN DING 1, MEI-HUA CHUANG 2, CHIN-YI LO 3, PEI-SHAN CHIANG 3 AND LI-HENG PAO 4*
1. Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, R.O.C.
2. Buddhist Dalin Tzu Chi General Hospital, Taipei, R.O.C.
3. Lotus Pharmaceutical Co.,LTD, Taipei, R.O.C.
4. School of Pharmacy, National Defense Medical Center, P.O. Box 90048-508, NeiHu,Taipei, R.O.C.
(Received: May 2, 2002; Accepted: July 10, 2002)
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 7.58±1.44 h and 8.12±1.31 μL/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.
Keywords: tranilast, pharmacokinetics, bioequivalence, Chinese.