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Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects.

Author(s): Si T, Shu L, Liu Y, Su YA, Guo C, Zhang H

Affiliation(s): Department of Clinical Psychopharmacology, Peking University Institute of Mental Health, Haidian District, Beijing, China. si.tian-mei@163.com

Publication date & source: 2010-07, Hum Psychopharmacol., 25(5):404-9.

Publication type: Research Support, Non-U.S. Gov't

OBJECTIVE: Paliperidone is the active metabolite of risperidone. This single-center, double-blind, randomized, single-dose study characterized the pharmacokinetics of 3 mg and 9 mg of paliperidone ER OROS in healthy Chinese subjects. METHODS: 24 subjects (13 male, 11 female), aged 19-35 years, with a BMI of 19.0-24.6 kg/m(2) participated. Blood samples were collected immediately before and over 96 h following single oral doses of 3 mg and 9 mg paliperidone. Plasma paliperidone concentrations were determined, and pharmacokinetic parameters were analyzed. RESULTS: Paliperidone's disposition after oral administration was characterized by a one-compartment pharmacokinetic model. Paliperidone was well absorbed (median t(max): 24 h after a 3-mg dose, and 26 h after a 9-mg dose). Apparent clearance and apparent volume of distribution were not significantly different between the two doses. C(max), AUC(0-t), and AUC(0-infinity) were dose-dependent. Pharmacokinetics was linear with respect to time; Geometric mean t(1/2) was 22.8 h and 21.4 h in 3-mg and 9-mg groups, respectively. No clinically significant safety issues were identified. CONCLUSIONS: The pharmacokinetic results obtained in Chinese subjects were similar to those obtained in Japanese and Caucasian subjects. (c) 2010 John Wiley & Sons, Ltd.

Page last updated: 2010-10-05

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