Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers.
- Author:
Shifen GU
1
;
Hui CHEN
;
Yinghai QIU
;
Shaojun SHI
;
Fandian ZENG
Author Information
1. Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030.
- Publication Type:Clinical Trial
- MeSH:
Adult;
Angiotensin Receptor Antagonists;
Biological Availability;
Biphenyl Compounds;
blood;
pharmacokinetics;
Capsules;
Cross-Over Studies;
Humans;
Male;
Tablets;
Tetrazoles;
blood;
pharmacokinetics
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2002;22(1):14-16
- CountryChina
- Language:English
-
Abstract:
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.
