生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Troxipide Tablet Formulations

Dewan Bhupesh and Sahu Navajit

Troxipide is a novel gastro protective agent with antiulcer, anti-inflammatory and mucus secreting properties. This bioequivalence study was carried out to determine the pharmacokinetic profile of troxipide in plasma in an open label, comparative, randomized, two way cross over design involving two treatments and two periods with one week washout period in 28 healthy male subjects. Blood samples were collected at intervals up to 28 hours, as per the approved protocol. Plasma concentrations of troxipide were analyzed by high performance liquid chromatography (HPLC) and noncompartmental method was used for pharmacokinetic analysis. The mean (±S.D.) values of the pharmacokinetic parameters (test vs. reference) were C max (1052.47±254.41 vs. 1039.10±301.54 ng ml -1 ), AUC (0-t) (8737.48±1545.24 vs. 8850.04±1892.63 ng h ml - 1 ), AUC (0- ∞ ) (9622.12±1692.57 vs. 9695.02±2133.95 ng h ml -1 ), and t ½ (7.44±1.85 vs. 7.24±2.10 h). There were no statistically significant differences between C max , AUC (0-t) and AUC (0- ∞ ) and their log transformed data (p>0.05) for the test and reference formulations. The 90% of confidence intervals (C.I.s) for the test/reference ratio of mean C max , AUC (0-t) , and AUC (0- ∞ ) were within the acceptable range of 80.00 to 125.00. The mean (±S.D.) times to maximal plasma concentration (t max ) of troxipide were 3.04±0.93 vs. 3.07±1.39 h for the test and the reference formulations respectively. Both the formulations were well tolerated. In conclusion, the two formulations were bioequivalent and may be used interchangeably.