2004Chinese Journal of PharmaceuticalsRequires access

Pharmacokinetics and Relative Bioavailability of Finasteride Tablets in Human

Xue Hong

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Abstract

The pharmacokinetics and relative bioavailability of test and reference tablets of finasteride wereinvestigated at a single oral dose of 10 mg in 20 healthy male volunteers, according to a randomized crossover design.The concentrations of finasteride in plasma were determined by a LC-MS method. The pharmacokinetic parameters wereCmax(94.15±18.71) and (99.13±20.10)ng/ml, tmax (2.2±0.7) and (2.4±0.9)h, t1/2(4.3±0.7) and (4.2±1.1)h,AUC0~24h(614.57±129.11) and (627.65±145.40)ng·h·ml-1, AUC0~∞(631.94±136.97) and (646.20±150.63) ng·h·ml-1 for test and reference tablets, respectively. The relative bioavailability of test tablets was(100.2±18.4)%. The results of variance analysis and two one-side t test showed that the tablets of two brands were bioequivalent.

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The pharmacokinetics and relative bioavailability of test and reference tablets of finasteride wereinvestigated at a single oral dose of 10 mg in 20 healthy male volunteers, according to a randomized crossover design.The concentrations of finasteride in plasma were determined by a LC-MS method. The pharmacokinetic parameters wereCmax(94.15±18.71) and (99.13±20.10)ng/ml, tmax (2.2±0.7) and (2.4±0.9)h, t1/2(4.3±0.7) and (4.2±1.1)h,AUC0~24h(614.57±129.11) and (627.65±145.40)ng·h·ml-1, AUC0~∞(631.94±136.97) and (646.20±150.63) ng·h·ml-1 for test and reference tablets, respectively. The relative bioavailability of test tablets was(100.2±18.4)%. The results of variance analysis and two one-side t test showed that the tablets of two brands were bioequivalent.

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Available abstract

The pharmacokinetics and relative bioavailability of test and reference tablets of finasteride wereinvestigated at a single oral dose of 10 mg in 20 healthy male volunteers, according to a randomized crossover design.The concentrations of finasteride in plasma were determined by a LC-MS method. The pharmacokinetic parameters wereCmax(94.15±18.71) and (99.13±20.10)ng/ml, tmax (2.2±0.7) and (2.4±0.9)h, t1/2(4.3±0.7) and (4.2±1.1)h,AUC0~24h(614.57±129.11) and (627.65±145.40)ng·h·ml-1, AUC0~∞(631.94±136.97) and (646.20±150.63) ng·h·ml-1 for test and reference tablets, respectively. The relative bioavailability of test tablets was(100.2±18.4)%. The results of variance analysis and two one-side t test showed that the tablets of two brands were bioequivalent.

Key concepts: Bioavailability, Bioequivalence, Pharmacokinetics, Chemistry, Finasteride, Crossover study, Pharmacology, Plasma concentration

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