Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers

Gu Shifen , Chen Hui , Qiu Yinghai , Shi Shaojun , Zeng Fandian

Current Medical Science ›› 2002, Vol. 22 ›› Issue (1) : 14 -16.

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Current Medical Science ›› 2002, Vol. 22 ›› Issue (1) : 14 -16. DOI: 10.1007/BF02904777
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Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers

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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 μg/ml, tmax: 1.44±0.34 h, t1/2: 20.21±14.71 h, AUC0−t; 11.087±3.443 μg/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.

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irbesartan / pharmacokinetics / bioavailability / HPLC

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Gu Shifen, Chen Hui, Qiu Yinghai, Shi Shaojun, Zeng Fandian. Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers. Current Medical Science, 2002, 22(1): 14-16 DOI:10.1007/BF02904777

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References

[1]

GillisJ C, MarkhamA. Irbesartan: a review of its pharmacodynamic and pharmacokinetics properties and therapeutic use in the management of hypertension. Drugs, 1997, 54(6): 885-885

[2]

VachharajaniN N, ShyuW C, ChandoT J, et al. . Oral bioavailability and disposition characteristics of irbesartan, an angiotension antagonist, in healthy volunteers. J Clin Pharmacol, 1998, 38: 702-702

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