Pharmacokinetics and bioavailability studies of generic ondansetron, and the innovator preparation, in healthy Thai male volunteers
Rojanasthien, N.; Manorot, M.; Kumsorn, B.; Nawoot, S.; Teekachunhatean, S.; Sangdee, C.; Apisariyakul, A.
Journal of the Medical Association of Thailand 82(7): 713-720
1999
ISSN/ISBN: 0125-2208 PMID: 10511774 Document Number: 1818
The pharmacokinetics and bioequivalence of two oral formulations of ondansetron were evaluated; Zetron(R) (Biolab Pharmaceutical, Bangkok, Thailand), as the test formulation and Zofran(R) (Glaxo Wellcome Operations, Greenford, UK), as the reference formulation. The two products were administered as a single oral dose of 8 mg according to a randomized two-way crossover design to 12 healthy Thai male volunteers. The washout period between treatment was 1 week. Ondansetron plasma concentrations were measured using HPLC. The oral bioavailability of ondansetron averaged 67 per cent and the elimination half-life after oral administration was 5.6 hours. The means and parametric 90 per cent CI of the ratios of Cmax and AUC0-alpha (mu Zetron(R) (Test) / mu Zofran(R) (Reference)) were 0.95 (0.84-1.07) and 0.94 (0.80-1.10), respectively. These values were well within the bioequivalence range of 0.8-1.25 as established by the US-FDA. The mean difference of Tmax (Test-Reference) was approximately 20 per cent. Thus, our study demonstrated bioequivalence of the two products (Zetron(R) and Zofran(R)) regarding the rate and extent of absorption.
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