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Absence of Food Effect on the Pharmacokinetics of Telbivudine Following Oral Administration in Healthy Subjects

From Idenix Pharmaceuticals Incorporated, Cambridge, Massachusetts.

The influence of food on the pharmacokinetics of telbivudine, a candidate antiviral agent against hepatitis B virus (HBV), was investigated in healthy adult subjects following a 600-mg oral dose administered with and without a high-fat/high-calorie meal. Telbivudine was well tolerated under fasting and fed conditions. Oral absorption of telbivudine as measured by maximum plasma concentration (C_max), time to reach C_max (T_max), and area under the plasma concentrationtime curve (AUC_0-t and AUC_0-) was not altered by food intake immediately before oral dosing. Values of C_max, T_max, and AUC were comparable when telbivudine was administered under fed and fasting conditions. Results from this study indicated that the absorption of telbivudine was not affected by a high-fat/high-calorie meal; telbivudine can therefore be administered orally with no regard to the timing of meals.

Key Words: Telbivudine • hepatitis B • antiviral • pharmacokinetics • food effect

Address for reprints: Xiao-Jian Zhou, PhD, Idenix Pharmaceuticals Inc, 60 Hampshire Street, Cambridge, MA 02139.

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