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Original ArticleOpen Access
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
,
Manorot M ,
Kumsorn B ,
Nawoot S ,
Teekachunhatean S ,
Sangdee C ,
Apisariyakul A The pharmacokinetics and bioequivalence of two oral formulations of ondansetron were
evaluated; Zetron® (Biolab Pharmaceutical, Bangkok, Thailand), as the test formulation 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-α [µ Zetron®
(Test) / µ 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.
Key word : Ondansetron, Generic, Innovator Preparation, Pharmacokinetics, Bioavailability, Healthy Thai
evaluated; Zetron® (Biolab Pharmaceutical, Bangkok, Thailand), as the test formulation 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-α [µ Zetron®
(Test) / µ 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.
Key word : Ondansetron, Generic, Innovator Preparation, Pharmacokinetics, Bioavailability, Healthy Thai
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