Title: Bioequivalence of Domestic and Imported Fluconazole Capsules in Healthy Volunteers
Abstract: Objective:To investigate the bioavailability of two brands of domestic Fluconazole capsules(preparation A and B) in healthy male volunteers so as to evaluate their bioequivalence with an imported Fluconazole capsules as reference(preparation R).Methods:In a 3-preparation and 3-period optimized Latin square design,18 healthy male volunteers were given a single oral dose of 300 mg test or reference capsules.The concentrations of Fluconazole in human plasma were determined with HPLC method with ultra-violet detector.Results:The main pharmacokinetic parameters of the test and reference capsules,preparation A,B and R were as follows:c_(max)were(5.39±0.90),(4.96±0.62) and(5.13±0.72) μg/ml;t_(max)(1.6±0.9),(1.7±0.7) and(2.2±0.8) h;AUC_(0~120h) were(215.8±31.8),(207.5±37.1) and(213.5±38.5) μg·h·ml~(-1);AUC_(0~∞) were(237.8±39.0),(232.4 ± 52.0) and(234.0±48.7) μg·h·ml~(-1);t_(1/2)were(34.7±5.9),(35.7±9.4) and(33.1±6.5) h,respectively.The relative bioavailabilities of the two test domestic capsules,preparation A and B,were(102.5±15.8)% and(97.9±12.1)%,respectively.Conclusion:The two test domestic preparations,A and B,were bioequivalent to the imported reference preparation.
Publication Year: 2006
Publication Date: 2006-01-01
Language: en
Type: article
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