中国临床药理学与治疗学2005，Vol.10Issue(4)：417-420,4.
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
Pharmacokinetics and relative bioavailability of telmisartan in male healthy Chinese volunteers
余俊先 1张银娣 1卓海通 1沈建平 1印晓星1
作者信息
- 1. 南京医科大学临床药理研究所,南京,210029,江苏
- 折叠
摘要
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.关键词
替米沙坦/药代动力学/相对生物利用度/高效液湘色谱法Key words
telmisartan/pharmacokinetics/bioavailability/HPLC分类
医药卫生引用本文复制引用
余俊先,张银娣,卓海通,沈建平,印晓星..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[J].中国临床药理学与治疗学,2005,10(4):417-420,4.
