Bioequivalence of Carpine Tablets Containing Carbamazepine

Abstract

Objective:

To develop a suitable assay method for carbamazepine and to use this method in the evaluation of a Malaysian-made generic tablet and a commercially available tablet containing carbamazepine for bioequivalence after a single-dose, randomized, 2-period, 2-treatment, 2-sequence crossover study.

Method:

Eighteen healthy men participated in the bioequivalence study. Each treatment was given as a single 2 × 200-mg dose. Plasma concentrations of carbamazepine were collected for up to 168 hours and assayed using HPLC.

Results:

The test to reference ratios were found to be 1.05 for maximum concentration (C_max), 1.02 for AUC(_0-t), 0.96 for AUC(_t-∞), 1.01 for AUC(_0-∞), and 0.99 for elimination half-life. The 90% confidence intervals of the AUC and C_max parameters were within the range of 0.80–1.25. Wilcoxon signed-rank test for paired samples showed no statistically significant difference between the t_max results.

Conclusions:

All of the parameters evaluated showed bioequivalence between the 2 formulations.