Comparative Bioavailability Study of Clonazepam After Oral Administration of Two Tablet Formulations
BL Chauhan+, SP Sane*, SN Revankar*, L Rammamurthy**, B Doshi+, AD Bhatt*, VR Bhate++, RD Kulkarni**
Novartis India Limited, Churchgate, Mumbai - 400 020; **Department of Pharmacology, MGM Medical College and Hospital, Kamothe, Sector 18, New Mumbai - 410 209; +Clin-Pharm Consultants, 284, Shree Krishna Niwas, B.A. Khimji Marg, Matunga, Mumbai - 400 019; ++Indtech Analytical Laboratory, A-227, Ansa Industrial Estate, Sakinaka, Mumbai - 400 072.
Received : 24.8.1999; Revised : 7.12.1999; Accepted : 30.3.2000
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 b and AUC (0-48) for Epitril were : 16.31 æ 3.07 ng/mL, 1.63 æ 0.48 h, 46.97 æ 12.26 h and 207.70 æ 57.07 ng/ml.h; for reference brand were 19.75 æ 5.95 ng/mL, 1.42 æ 0.29 h, 46.88 æ 11.29 h and 215.70 æ 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. (JAPI 2000; 48 : 985-987)