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


CONCLUSIONS
Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
Chauhan
B L
BL
Novartis India Limited, Churchgate, Mumbai-400 020.
Sane
S P
SP
Revankar
S N
SN
Rammamurthy
L
L
Doshi
B
B
Bhatt
A D
AD
Bhate
V R
VR
Kulkarni
R D
RD
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D002998:Clonazepam / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012680:Sensitivity and Specificity; D013607:Tablets
D013607:Tablets; D002998:Clonazepam