| Research Article |
Open Access |
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| Bioequivalence Study of Troxipide Tablet Formulations |
| Dewan Bhupesh*, Sahu Navajit |
| Zuventus Healthcare Ltd., 5119 ‘D’ Wing, Oberoi Garden Estate, Chandivilli, Mumbai 400 072, India. |
| *Corresponding author: |
Dr. Bhupesh Dewan, M.B.B.S, M.D.,
Chief Medical Advisor,
Zuventus Healthcare Ltd., 5119 ‘D’ Wing,
Oberoi Garden Estate, Chandivilli,
Mumbai 400 072,
Tel: +91 (0) 2230610000 / 28472823/24,
Fax: +91 (0) 2228472828/29,
E-mail: bhupesh.dewan@zuventus.com |
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| Received February 26, 2010; Accepted April 04, 2010; Published April 04, 2010 |
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| Citation: Dewan B, Sahu N (2010) Bioequivalence Study of Troxipide Tablet Formulations. J Bioequiv Availab 2: 050-054. doi: 10.4172/jbb.1000030 |
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| Copyright: © 2010 Dewan B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
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| Abstract |
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 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 h
ml-1), and t½ (7.44±1.85 vs. 7.24±2.10 h). There were no
statistically significant differences between Cmax, 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 Cmax,
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 (tmax) 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. |
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