Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers.
The pharmacokinetics and relative bioavailability were studied in 18 healthy volunteers. A single oral dose of 150 mg irbesartan capsule (test) or tablet (reference) was given to each volunteer according to a randomized 2-way crossover study. The concentrations in plasma were determined by HPLC-UV method. The main parameters of irbesartan capsules were: Cmax: 1.502 +/- 0.295 micrograms/ml, tmax: 1.44 +/- 0.34 h, t 1/2: 20.21 +/- 14.71 h, AUC0-t: 11.087 +/- 3.443 micrograms/ml-1.h. The relative bioavailability of capsule to tablet was (101.4 +/- 28.9)%. The results of statistical analysis showed that two formulations were bioequivalent.
Gu
Shifen
S
Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030.
Chen
Hui
H
Qiu
Yinghai
Y
Shi
Shaojun
S
Zeng
Fandian
F
D000328:Adult; D057911:Angiotensin Receptor Antagonists; D001682:Biological Availability; D001713:Biphenyl Compounds / Q000097:blood / Q000493:pharmacokinetics*; D002214:Capsules; D018592:Cross-Over Studies; D006801:Humans; D000077405:Irbesartan; D008297:Male; D013607:Tablets; D013777:Tetrazoles / Q000097:blood / Q000493:pharmacokinetics*
D057911:Angiotensin Receptor Antagonists; D001713:Biphenyl Compounds; D002214:Capsules; D013607:Tablets; D013777:Tetrazoles; D000077405:Irbesartan