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J Assoc Physicians India. 2000 Oct;48(10):985-7.

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

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1
Novartis India Limited, Churchgate, Mumbai-400 020.

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.

PMID:
11200924
[Indexed for MEDLINE]
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