Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.

Chauhan, B L; Sane, S P; Revankar, S N; Rammamurthy, L; Doshi, B; Bhatt, A D; Bhate, V R; Kulkarni, R D

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Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.

Chauhan, B L; Sane, S P; Revankar, S N; Rammamurthy, L; Doshi, B; Bhatt, A D; Bhate, V R; Kulkarni, R D.

Artículo en Inglés | IMSEAR | ID: sea-87212

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.

Asunto(s)

Administración Oral Adulto Análisis de Varianza Disponibilidad Biológica Química Farmacéutica Cromatografía Líquida de Alta Presión Clonazepam/administración & dosificación Estudios Cruzados Humanos Masculino Persona de Mediana Edad Valores de Referencia Sensibilidad y Especificidad Comprimidos

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Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Asunto(s)