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

Author(s): Chauhan BL, Sane SP, Revankar SN, Rammamurthy L, Doshi B, Bhatt AD, Bhate VR, Kulkarni RD

Affiliation(s): Novartis India Limited, Churchgate, Mumbai-400 020.

Publication date & source: 2000-10, J Assoc Physicians India., 48(10):985-7.

Publication type: Clinical Trial; Randomized Controlled Trial

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.