Chauhan, B LSane, S PRevankar, S NRammamurthy, LDoshi, BBhatt, A DBhate, V RKulkarni, R D2000-10-242009-05-302000-10-242009-05-302000-10-24Chauhan BL, Sane SP, Revankar SN, Rammamurthy L, Doshi B, Bhatt AD, Bhate VR, Kulkarni RD. Comparative bioavailability study of clonazepam after oral administration of two tablet formulations. Journal of the Association of Physicians of India. 2000 Oct; 48(10): 985-7http://imsear.searo.who.int/handle/123456789/87212OBJECTIVE: 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.engAdministration, OralAdultAnalysis of VarianceBiological AvailabilityChemistry, PharmaceuticalChromatography, High Pressure LiquidClonazepam --administration & dosageCross-Over StudiesHumansMaleMiddle AgedReference ValuesSensitivity and SpecificityTabletsClinical Trial