Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.
Artículo
en Inglés
| IMSEAR
| ID: sea-87212
ABSTRACT
OBJECTIVE:
To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand.METHODS:
A two-way randomised cross-over bioavailability study was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of clonazepam by high performance liquid chromatography (HPLC) method.RESULTS:
The mean Cmax, Tmax t1/2 beta and AUC (0-48) for Epitril were 16.31 +/- 3.07 ng/mL, 1.63 +/- 0.48 h, 46.97 +/- 12.26 h and 207.70 +/- 57.07 ng/ml.h; for reference brand were 19.75 +/- 5.95 ng/mL, 1.42 +/- 0.29 h, 46.88 +/- 11.29 h and 215.70 +/- 50.89 ng/ml.h respectively. These were comparable and the differences were not statistically significant.CONCLUSION:
Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
Texto completo:
Disponible
Índice:
IMSEAR (Asia Sudoriental)
Asunto principal:
Valores de Referencia
/
Comprimidos
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Humanos
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Masculino
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Disponibilidad Biológica
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Química Farmacéutica
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Administración Oral
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Análisis de Varianza
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Cromatografía Líquida de Alta Presión
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Sensibilidad y Especificidad
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio diagnóstico
Idioma:
Inglés
Año:
2000
Tipo del documento:
Artículo
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