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BIOEQUIVALENCE OF
CARPINE TABLETS CONTAINING CARBAMAZEPINE
Yahaya Hassan,
Yvonne T Tan, Kok-Khiang Peh, Noorizan Abd Aziz,
Ab Fatah Ab Rahman,
Nornisah Mohamed, and Omar Ismail
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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.
METHODS: 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 (Cmax), 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 Cmax parameters were within the range of 0.80–1.25. Wilcoxon signed-rank test for paired samples showed no statistically significant difference between the tmax results.
CONCLUSIONS: All of the parameters evaluated showed bioequivalence between the 2 formulations.
J Pharm Technol 2003;19:278-82.
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