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- 저자 : Peyman Nayyeri-Maleki (검색결과 1 건)
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Hadi Valizadeh,Parvin Zakeri-Milani,Peyman Nayyeri-Maleki,Saeed Ghanbarzadeh,Ahad Sheikhloo,Hossein Servat,Mahboob Nemati 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.1
The aim of this study was to evaluate thepharmacokinetics (PK) and bioequivalence (BE) of twometformin tablets. For in vitro evaluation, weight variation,assay and dissolution tests were performed. A randomized,single dose, two-period, cross over study in healthy malefasting volunteers was designed. A 2-week washout periodseparated the two periods. For analysis of PK parametersblood sampling was performed before and after drugadministration in various time points up to 12 h. Metforminconcentration in plasma was determined using a developedhigh performance liquid chromatography method. Bothformulations passed the assay, content uniformity, and dissolutiontests acceptance value. PK parameters, representingthe rate and the extent of metformin absorption were calculatedand analyzed for two formulations. The 90 % CIobtained by analysis of variance for the ratios of Cmax,AUC0–t, and AUC0–? were 92.14–110.95, 92.72–107.37and 89.42–110.23 % respectively, meeting the criteria forBE (80–125 %). Administration of a single dose of test andreference formulations did not result in statistically significantdifferences between in vitro and in vivo BE parametersin healthy Iranian male volunteers. Thus in the case of rateand extent of absorption the test and reference formulationswere considered bioequivalent.
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