Title: Pharmacokinetics and in vitro-in vivo correlation of sustained-release metformin in healthy volunteers
Abstract: Objective The single-dose and multi-dose pharmacokinetics of two sustained-release tablet formulations of metformin hydrochloride in fed, 40 healthy volunteers were compared, and their in vitro-in vivo correlations were evaluated. Methods Self-made and imported (Glucophage XP) sustained-release tablets of metformin hydrochloride were administered orally in a single-dose, 1000 mg/d for two times with a 6-day interval, or the multi-dose regimen of 1000 mg/d for two blocks of five-consecutive days with a 14-day interval. The plasma concentrations and pharmacokinetics of metformin hydrochloride were analyzed after administration. The in vivo drug release rate was compared with in vivo Absorption percentage calculated from Wagner-Nelson method for getting the in vitro-in vivo correlation. Result and Conclusion The two formulations have similar phamarcokinetics and bioequivalent, and their in vitro-in vivo correlations are good.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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