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

To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand. 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 l...

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Bibliographic Details
Published in:	Journal of the Association of Physicians of India Vol. 48; no. 10; p. 985
Main Authors:	Chauhan, B L, Sane, S P, Revankar, S N, Rammamurthy, L, Doshi, B, Bhatt, A D, Bhate, V R, Kulkarni, R D
Format:	Journal Article
Language:	English
Published:	India 01-10-2000
Subjects:	Administration, Oral Adult Analysis of Variance Biological Availability Chemistry, Pharmaceutical Chromatography, High Pressure Liquid Clonazepam - administration & dosage Clonazepam - pharmacokinetics Cross-Over Studies Humans Male Middle Aged Reference Values Sensitivity and Specificity Tablets
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Summary:	To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand. 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. 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. Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
ISSN:	0004-5772