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2006•Chinese Journal of PharmaceuticalsRequires access

Bioequivalence of Famciclovir Dispersible Tablets in Human

Yan Hou

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Abstract

The bioequivalence of famciclovir dispersible tablets and film-coated tablets was investigated with a randomized crossover design at a single oral dose of 250mg in 18 healthy male volunteers. The concentration of penci-clovir, the active metabolite in human plasma after administration of famciclovir, was determined by a HPLC method. The results showed that AUC0→8h and AUC0→∞ of the two preparations had no significant difference, Cmax of the disper-sible tablets increased and Tmax decreased. The relative bioavailability of dispersible tablets was(104.7±12.9)%. The results of two one-side t test showed that the two preparations were bioequivalent.

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What this paper is about

The bioequivalence of famciclovir dispersible tablets and film-coated tablets was investigated with a randomized crossover design at a single oral dose of 250mg in 18 healthy male volunteers. The concentration of penci-clovir, the active metabolite in human plasma after administration of famciclovir, was determined by a HPLC method. The results showed that AUC0→8h and AUC0→∞ of the two preparations had no significant difference, Cmax of the disper-sible tablets increased and Tmax decreased. The relative bioavailability of dispersible tablets was(104.7±12.9)%. The results of two one-side t test showed that the two preparations were bioequivalent.

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Available abstract

The bioequivalence of famciclovir dispersible tablets and film-coated tablets was investigated with a randomized crossover design at a single oral dose of 250mg in 18 healthy male volunteers. The concentration of penci-clovir, the active metabolite in human plasma after administration of famciclovir, was determined by a HPLC method. The results showed that AUC0→8h and AUC0→∞ of the two preparations had no significant difference, Cmax of the disper-sible tablets increased and Tmax decreased. The relative bioavailability of dispersible tablets was(104.7±12.9)%. The results of two one-side t test showed that the two preparations were bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Cmax, Famciclovir, Chemistry, Pharmacology, Pharmacokinetics, Crossover study

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