Food effect on the pharmacokinetics of entecavir from dispersible tablets following oral administration in healthy Chinese volunteers
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The aim of the present study was to assess the effect of food on the pharmacokinetics of entecavir (CAS 142217-69-4) from dispersible tablets. Methods: In an open-label, two-way crossover study, 12 healthy Chinese volunteers randomly received a single oral dose of 1 mg entecavir dispersible tablets under fasted and fed conditions. Blood samples were collected and determined for pharmacokinetic analyses. A solid phase extraction for sample preparation and a LC/MS method were developed and validated for determination of entecavir in human plasma. Results: The absorption of entecavir from dispersible tablets was altered significantly with food intake, as evidenced by a decrease in Cmax of 63 %, a decrease in AUC0?t of 22 %, and a delay in Tmax of 1.5 h. The calibration curve was linear from 0.2 to 25 ng/mL, with a lower limit of quantitation (LLOQ) of 0.2 ng/mL. Conclusion: Food intake has an obvious effect on the absorption of entecavir from dispersible tablets. It is better to take entecavir dispersible tablets on an empty stomach.
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