Pharmacokinetics and relative bioavailability of telmisartan in male healthy Chinese volunteers
- VernacularTitle:替米沙坦在中国健康人体内的药代动力学和相对生物利用度研究
- Author:
Junxian YU
;
Yindi ZHANG
;
Haitong ZHUO
;
Jianping SHEN
;
Xiaoxing YIN
- Publication Type:Journal Article
- Keywords:
telmisartan;
pharmacokinetics;
bioavailability;
HPLC
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2005;10(4):417-420
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To compare pharmacokinetics and relative bioavailability of telmisartan capsule (T) and telmisartan tablet(R). METHODS: 20 male healthy Chinese volunteers were enrolled in a randomized two-way crossover designs with a single-oral dose study(80 mg once per day for each preparation). The plasma telmisatan concentration was determined by HPLC- fluorescence detector. Plasma levels of telmisatan were followed up to 96 h. Area under the telmisartan concentration time curve was calculated by variance analysis and the bioequivalent was determined by two one-side t-test. RESULTS: A two-compartment model was adopted in telmisartan plasma concentration-time data analysis. The pharmacokinetic parameters of T and R in single-dose study including Cmax (μg·L-1), Tmax (h), T1/2β (h), MRT(h), AUC0-92(μg·h·L-1) were as following: 456±253 and 760±314, 1.61±0.71 and 1.08±0.36, 22.39±6.29 and 21.08±5.24, 27.02±6.23 and 24.27±5.79, 3454±1050 and 3635±1300, respectively. Statistically significant differences were observed between the parameter values of the two products in Cmax and Tmax; whereas there was no statistically significant difference between AUC0-∞μg·h·L-1 (3601±1095 and 3767±1399). The relative bioavailability for T was 97.28%±12.74%. CONCLUSION: The test telmisartan capsule is bioequivalent to the reference tablet.
