Publication: Bioequivalence study of 300 mg irbesartan film-coated tablets preparations in healthy Thai volunteers
Issued Date
2013-01-01
Resource Type
ISSN
19054637
01254685
01254685
Other identifier(s)
2-s2.0-84905825780
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Thai Journal of Pharmaceutical Sciences. Vol.37, No.4 (2013), 186-193
Suggested Citation
Porranee Puranajoti, Peerawong Werarak, Burapat Intawong, Jarunee Hongrapipat, Rungrudee Talubsri, Soravee Sangsuriyawong, Temsiri Kuamsuk Bioequivalence study of 300 mg irbesartan film-coated tablets preparations in healthy Thai volunteers. Thai Journal of Pharmaceutical Sciences. Vol.37, No.4 (2013), 186-193. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/32753
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Bioequivalence study of 300 mg irbesartan film-coated tablets preparations in healthy Thai volunteers
Other Contributor(s)
Abstract
Irbesartan, an angiotensin II receptor antagonist, is indicated for the treatment of essential hypertension alone or in combination with other antihypertensive agents. The purpose of this study was to compare the bioavailability of two formulations of irbesartan 300 mg film-coated tablets administered orally in Thai healthy volunteers. One formulation was a generic product named "irbesartan 300 mg film-coated tablet" which was a representative of a "test drug" in this study. Another was an innovator product of irbesartan 300 mg tablet commercially available in the market which was a representative of a "reference drug". An open-label, single dose, randomized crossover study was designed and conducted in 26 healthy Thai volunteers. Each subject received both formulations of irbesartan 300 mg tablet with respect to either reference drug or test drug in each period. Blood samples were collected prior to dosing and at various blood collection time points after dosing up to 72 hours and irbesartan concentrations in plasma samples were determined using a validated High Performance Liquid Chromatography (HPLC) method with fluorescence. The pharmacokinetic parameters including Cmax, AUC0-t, and AUC0_inf were statistically compared in order to evaluate the bioequivalence of the two formulations. Drug safety and tolerability were assessed. Twenty-six volunteers completed both treatment periods. It was found that 90% confidence intervals for the log-transformed test/reference ratios of irbesartan were 103.71% (90% CI, 94.86-113.39%) for Cmax, 92.91% (90% CI, 86.27-100.08%) for AUC0-tlast, and 92.81% (90% CI, 86.11-100.03%) for AUC0-inf. The results of statistical analysis showed that two formulations were bioequivalent in terms of both rate and extent of absorption according to the guideline of the Food and Drug Administration of Thailand.