Relative bioavailability of two brands of ornidazole in twelve healthy volunteers.

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dc.contributor.authorRamamurthy, Len_US
dc.contributor.authorKulkarni, R Den_US
dc.contributor.authorChauhan, B Len_US
dc.contributor.authorSharma, D Ren_US
dc.contributor.authorSingh, Aen_US
dc.date.accessioned2002-09-09en_US
dc.date.accessioned2009-05-31T00:31:14Z
dc.date.available2002-09-09en_US
dc.date.available2009-05-31T00:31:14Z
dc.date.issued2002-09-09en_US
dc.description.abstractAIM OF THE STUDY: To determine the bioequivalence of two marketed ornidazole formulations in healthy volunteers. METHODOLOGY: A single dose relative bioavailability of Ornidazole 1.5 g (3 x 500 mg tablets) of test product (Giro, Panacea Biotec Ltd.) and that of standard reference (Dazolic, Sun Pharmaceutical Industries), was investigated in healthy adult males. A total of 12 subjects wee enrolled in the study and investigations consisted of two treatment phases separated by a washout period of seven days. Both treatment phases were of 12 hours durations each. Blood samples were collected at 0, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post-administration of assigned drug product. Appropriate fasting restrictions were employed during both the treatment phases. Drug assay was done using HPTLC method. The statistical significance of difference in pharmacokinetic parameters between preparations was tested using ANOVA. RESULTS: The mean peak plasma concentration (Cmax) of 32.67 +/- 4.45 microg/ml was achieved at 1.54 +/- 0.81 hours following administration of test product as against mean Cmax of 31.55 +/- 5.04 microg/ml at 1.79 +/- 0.89 hours for reference standard. The area under time concentration curve (AUC(0-12)) hours was 261.67 +/- 77 microg/ml hours with reference standard and 265.41 +/- 30.82 microg/ml hours for test product. CONCLUSION: There was no statistically significant difference between the two formulations and the two productsen_US
dc.description.affiliationDepartment of Pharmacology, MGM Medical College, New Mumbai.en_US
dc.identifier.citationRamamurthy L, Kulkarni RD, Chauhan BL, Sharma DR, Singh A. Relative bioavailability of two brands of ornidazole in twelve healthy volunteers. Journal of the Association of Physicians of India. 2002 Sep; 50(): 1149-52en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/91378
dc.language.isoengen_US
dc.source.urihttps://www.japi.orgen_US
dc.subject.meshAdulten_US
dc.subject.meshAntitrichomonal Agents --pharmacokineticsen_US
dc.subject.meshBiological Availabilityen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshOrnidazole --pharmacokineticsen_US
dc.subject.meshReference Valuesen_US
dc.subject.meshTime Factorsen_US
dc.titleRelative bioavailability of two brands of ornidazole in twelve healthy volunteers.en_US
dc.typeComparative Studyen_US
dc.typeJournal Articleen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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