Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers.
- Author:
Shifen, GU
;
Hui, CHEN
;
Yinghai, QIU
;
Shaojun, SHI
;
Fandian, ZENG
- Publication Type:Clinical Trial
- MeSH:
Biological Availability;
Biphenyl Compounds/blood;
Biphenyl Compounds/*pharmacokinetics;
Capsules;
Cross-Over Studies;
Receptors, Angiotensin/*antagonists & inhibitors;
Tablets;
Tetrazoles/blood;
Tetrazoles/*pharmacokinetics
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2002;22(1):14-6
- 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.