Pharmacokinetics and bioavailability studies of generic ondansetron, and the innovator preparation, in healthy Thai male volunteers.
Artigo
em Inglês
| IMSEAR
| ID: sea-41072
ABSTRACT
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 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 AUC 0-alpha [mu Zetron (Test)/mu Zofran (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 and Zofran) regarding the rate and extent of absorption.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Assunto principal:
Valores de Referência
/
Tailândia
/
Humanos
/
Masculino
/
Disponibilidade Biológica
/
Química Farmacêutica
/
Sensibilidade e Especificidade
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Adolescente
/
Medicamentos Genéricos
/
Ondansetron
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo diagnóstico
/
Estudo prognóstico
País/Região como assunto:
Ásia
Idioma:
Inglês
Ano de publicação:
1999
Tipo de documento:
Artigo
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