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International Journal of Pharmacology

Year: 2006 | Volume: 2 | Issue: 5 | Page No.: 481-484
DOI: 10.3923/ijp.2006.481.484
Pharmacokinetics and Bioequivalence Study of Clobazam 10 mg Tablet
Mohammad Reza Rouini, Yalda H. Ardakani, Majid Shohrati, Lida Hakemi, Gheise Badri and Maryam Mokhberi

Abstract: The bioequivalence of two brands of clobazam 10 mg tablets was demonstrated in this study. A single dose was carried out in 14 healthy volunteers with a two-sequence, crossover block-randomized design. Blood samples were taken prior to each administration and at 18 points within 72 h after the dose administration. Plasma concentrations of clobazam and N-desmethylclobazam were determined by HPLC method. The pharmacokinetic parameters, Cmax and Tmax were obtained directly from plasma concentration-time profiles. ke was estimated by log-linear regression and AUC was calculated by the linear trapezoidal rule for both clobazam and N-desmethylclobazam. The pharmacokinetic parameters, AUC(0-t), AUC(0-∞) and Cmax were tested for equivalence after logtransformation of data. Differences of Tmax were evaluated by a non-parametric test. The 90% confidence intervals of the mean values for the test/reference ratios were 94-103% for AUC(0-t), 90-110% for AUC(0-∞) and 87-109% for Cmax, which were within the acceptable bioequivalence limits of 80-125% for clobazam. Based on desmethylclobazam data, the 90% confidence interval for AUC(0-t) and Cmax were calculated to be 82-106% and 81-117% respectively. Therefore two formulations were considered bioequivalent.

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How to cite this article
Mohammad Reza Rouini, Yalda H. Ardakani, Majid Shohrati, Lida Hakemi, Gheise Badri and Maryam Mokhberi, 2006. Pharmacokinetics and Bioequivalence Study of Clobazam 10 mg Tablet. International Journal of Pharmacology, 2: 481-484.

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