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Bioequivalence Study of Troxipide Tablet Formulations

Author(s): Dewan Bhupesh | Sahu Navajit

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 02;
Issue: 02;
Start page: 050;
Date: 2010;
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Keywords: Troxipide | Pharmacokinetics | Bioequivalence | High performance liquid chromatography

Troxipide is a novel gastro protective agent with antiulcer,anti-inflammatory and mucus secreting properties. Thisbioequivalence study was carried out to determine thepharmacokinetic profile of troxipide in plasma in an openlabel, comparative, randomized, two way cross over designinvolving two treatments and two periods with one weekwashout period in 28 healthy male subjects.Blood samples were collected at intervals up to 28 hours,as per the approved protocol. Plasma concentrations oftroxipide were analyzed by high performance liquidchromatography (HPLC) and noncompartmental methodwas used for pharmacokinetic analysis. The mean (±S.D.)values of the pharmacokinetic parameters (test vs. reference)were Cmax (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 hml-1), and t½ (7.44±1.85 vs. 7.24±2.10 h). There were nostatistically significant differences between Cmax, AUC(0-t)and AUC(0-¥) and their log transformed data (p>0.05) forthe test and reference formulations. The 90% of confidenceintervals (C.I.s) for the test/reference ratio of mean Cmax,AUC(0-t), and AUC(0-¥) were within the acceptable range of80.00 to 125.00. The mean (±S.D.) times to maximal plasmaconcentration (tmax) of troxipide were 3.04±0.93 vs.3.07±1.39 h for the test and the reference formulationsrespectively. Both the formulations were well tolerated.In conclusion, the two formulations were bioequivalentand may be used interchangeably.
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