Relative bioavailability of domestic and imported telmisartan tablets in healthy volunteers

被引：0

作者：

Li, Tao ^{[1
]}

Feng, Yu-Fei ^{[1
]}

Liu, Lei ^{[1
]}

Li, Ke-Xin ^{[1
]}

Sun, Chun-Hua ^{[1
]}

机构：

[1] Beijing Hospital, Beijing 100730, China

来源：

Chinese Pharmaceutical Journal | 2005年 / 40卷 / 15期

关键词：

Bioassay - Body fluids - Concentration (process) - Drug dosage - High performance liquid chromatography - Pharmacokinetics - Synthesis (chemical);

D O I：

1001-2494(2005)15-1167-03

中图分类号：

学科分类号：

摘要：

OBJECTIVE: To study the bioavailability of domestic and imported telmisartan tablets and evaluate its bioequivalence in healthy volunteers. METHODS: A single oral dose of 80 mg domestic and imported telmisartan tablets was given to 24 healthy male volunteers according to an open randomized 2 way crossover design. The plasma concentration of telmisartan was determined by a HPLC assay. RESULTS: The pharmacokinetic parameters of the two products were as follows: tmax (0.82 ± 0.33) and (0.81 ± 0.20) h, ρmax (560.94 ± 229.23) and (602.75 ± 212.71) μg&middotL-1, AUC0-t (3 231.42 ± 1 353.49) and (3 304.46 ± 1 308.97) μg&middoth&middotL-1, respectively. The relative bioavailability of domestic product was (98.2 ± 11.5) %. CONCLUSION: Two preparations were bioequivalence.

引用

页码：1167 / 1169