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Article Title

Pharmacokinetic behavior of ketoconazole in adult Chinese males

Abstract

The pharmacokinetic behavior of ketoconazole (Nizoral-Janssen) in Chinese adults was studied in 14 male volunteers. The pharmacokinetic parameters of ketoconazole obtained after oral administration of 400 mg (two tablets) were AUC (51.4 ± 17.9 mg.h/l, mean ± SD), C(max) (10.3 ± 2.8 mg/l), T(max) (1.5 ± 0.3 h), MRT (4.1 ± 0.7 h), VRT (30.9 ± 11.2 h2), CI/F/BW (0.138 ± 0.063 l/h/kg) and k* (slope of terminal phase, 0.330 ± 0.09 h-1). When the plasma concentration data of 14 subjects were fitted to a conventional one-compartment body model, then the first order absorption rate constant was 0.236 ± 0.136 h-1, and the elimination rate constant was 0.172 ± 0.041 h-1. No statistical difference was observed for the parameters CL/F, k*, C(max) and AUC between Caucasians in a published study and Chinese in this study (p > 0.1). However, the T(max) in Chinese (1.5 ± 0.3 h) was significantly shorter than that in Caucasians (2.6 ± 1.2 h, p < 0.01).

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