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Single-Dose and Multiple-Dose Pharmacokinetics and Safety of Telbivudine After Oral Administration in Healthy Chinese Subjects

From the Peking Union Medical College Hospital, Beijing, People's Republic of China (Dr Hu, Dr Jiang, Dr Wang), and Idenix Pharmaceuticals Inc, Cambridge, Massachusetts (Mr Pietropaolo, Dr Chao, Dr Brown, Dr Zhou).

The pharmacokinetics of telbivudine, an L-nucleoside with potent activity against hepatitis B virus, was assessed in 42 healthy Chinese volunteers. Subjects were assigned to receive a single oral dose of 200, 400, or 800 mg telbivudine or repeat doses of 600 mg/d. Telbivudine was absorbed rapidly and exhibited dose-related plasma exposure. After reaching maximum concentration (C_max) at a median time of 2.0 to 2.5 hours, plasma disposition of the drug was biphasic with a mean terminal half-life ranging from 39.4 to 49.1 hours. Telbivudine accumulated slightly after repeat doses, and steady state was reached after 5 to 6 consecutive doses of 600 mg/d. The mean steady-state C_max and area under the plasma concentration–time curve over the dosing interval of telbivudine 600 mg were 3.7 µg/mL and 26.1 µg·h/mL, respectively. Cumulative urinary excretion of telbivudine over 32 hours represented 24.4% of the administered dose, with a mean renal clearance of 6.6 L/h. Telbivudine was well tolerated in the studied dose range in healthy Chinese subjects, with no pattern of dose-related clinical or laboratory adverse events.

Key Words: Telbivudine • hepatitis B • pharmacokinetics • Chinese subjects

Address for reprints: Xiao-Jian Zhou, PhD, Idenix Pharmaceuticals Inc, 60 Hampshire Street, Cambridge, MA 02139; e-mail: zhou.xiao-jian{at}idenix.com.

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