Pharmacokinetics and Bioavailability Studies of ~eneric
Ondansetron, and the Innovator Preparation, in Healthy
Thai Male Volunteers
NOPPAMAS ROJANASTHIEN, M.D.*,
BOONYIUM KUMSORN, B.Sc.*,
SUPANIMIT TEEKACHUNHATEAN, M.D.*,
AMPHA WAN APISARIY AKUL, Ph.D.*
MALEEYA MANOROT, M.D.*,
SOPON NAWOOT, M.D.**,
CHAICHAN SANGDEE, Ph.D.*,
Affiliation : * Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200,
** Lanna Hospital, Chiang Mai 50300, Thailand.
AbstractThe pharmacokinetics and bioequivalence of two oral formulations of ondansetro1_1 were
evaluated; Zetron® (Biolab Pharmaceutical, Bangkok, Thailand), as the test fo~mulation and
Zofran® (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 I
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 AUC 0-a [J-1 Zetron®
(Test) I J-1 Zofran ® (Reference)) were 0.95 (0.84- 1.07) and 0.94 (0.80- I. I 0), 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® and Zofran®) regarding the rate and
extent of absorption.
Keywords : Ondansetron, Generic, Innovator Preparation, Pharmacokinetics, Bioavailability,
Healthy Thai
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