Evaluation of the bioequivalence of zidovudine 100 mg capsules in healthy Thai male volunteers.

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dc.contributor.authorChompootaweep, Sumanaen_US
dc.contributor.authorPoonsrisawat, Jitisaken_US
dc.contributor.authorXumseang, Pratoommalen_US
dc.date.accessioned2009-05-27T18:38:46Z
dc.date.available2009-05-27T18:38:46Z
dc.date.issued2006-09-28en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractOBJECTIVE: The bioequivalence study of two oral formulations of zidovudine were evaluated; Antivir (Government Pharmaceutical Organization (GPO), Thailand) as the test formulation and Retrovir (Glaxo-SmithKline, USA), as the reference formulation. MATERIAL AND METHOD: The two products were orally administered as a single dose of 100 mg zidovudine three capsules according to a randomized two-way crossover design to 28 healthy fasted Thai male volunteers. The washout period between treatments was 1 week. After drug administration, serial blood samples were collected at a specific time interval from 0-10 hours. The plasma zidovudine concentrations were determined via HPLC technique. Individual plasma zidovudine concentration-time profile was analyzed for relevant pharmacokinetic parameters; the comparative bioavailability of the two products was determined by the analysis of variance (ANOVA) for two way crossover design, using logarithmic transformed data. RESULTS: The results found that the mean peak (X+/- SD) plasma concentration (Cmax) of Antivir was 3.34 +/- 0.15 ng/mL and of Retrovir was 3.32 +/- 0.21 ng/mL. The 90% confidence interval (CI) for the difference of mean Cmax was 90.76-120.81%. The time to peak plasma concentration (Tmax) of Antivir was 0.49 +/- 0.16 hours and for Retrovir was 0.62 +/- 0.35 hours with a difference time to peak of 20.96%. The half life (t1/2) of Antivir was 1.16 +/- 0.28 hours and t1/2 of Retrovir was 1.05 +/- 0.25 hours. The mean area under the curve (AUC0-->t) of Antivir was 3.34 +/- 0.12 ng.hr/mL and of Retrovir was 3.35 +/- 0.15 ng.hr/mL. The 90%CI for the difference ofmean AUC0-->t was 91.83-103.99%. The mean AUC0-->infinity of Antivir was 3.37 +/- 0.12 nghr/mL and for and Retrovir was 3.38 +/- 0.14 ng.hr/mL. The 90%CI for the difference of mean AUC0-->infinity was 91.22-104.69%. CONCLUSION: The present study revealed that the 90%CI for the difference of Cmax AUC0-->t and AUC0-->infinity means were in the criteria ofacceptance, which should be within 80-125%. Thus, the present study demonstrated the bioequivalence of the test drug (Antivir) and the reference drug (Retrovir).en_US
dc.description.affiliationDepartment of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.en_US
dc.identifier.citationChompootaweep S, Poonsrisawat J, Xumseang P. Evaluation of the bioequivalence of zidovudine 100 mg capsules in healthy Thai male volunteers. Journal of the Medical Association of Thailand. 2006 Sep; 89 Suppl 3(): S79-85en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/39565
dc.language.isoengen_US
dc.source.urihttps://www.mat.or.th/journal/all.phpen_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdulten_US
dc.subject.meshAnalysis of Varianceen_US
dc.subject.meshAnti-HIV Agents --administration & dosageen_US
dc.subject.meshArea Under Curveen_US
dc.subject.meshCapsulesen_US
dc.subject.meshChromatography, High Pressure Liquiden_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshThailanden_US
dc.subject.meshTherapeutic Equivalencyen_US
dc.subject.meshZidovudine --administration & dosageen_US
dc.titleEvaluation of the bioequivalence of zidovudine 100 mg capsules in healthy Thai male volunteers.en_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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