Pharmacokinetics and bioavailability of sustained release and conventional formulation of acyclovir.

The pharmacokinetics and relative bioavailability of a new sustained release formulation (200mg) of acyclovir (ACV) in comparison with a 100mg reference was investigated. The studies were conducted in two-way crossover design, as single and multiple oral administration in twelve healthy volunteers. Serum samples were assayed for ACV using a high-performance liquid chromatography (HPLC) method with UV detection. The bioavailability of sustained release tablets relative to conventional tablets following single and multiple dosing was 105.9 +/- 12.0% and 95.2 +/- 8.4%, respectively. ANOVA and the two-sided t-test procedures showed significant difference in Cmax and tmax but no difference was found in AUC both in single and multiple dose studies. The results of this study indicated that the new sustained release tablets and the reference are bioequivalent.

RCT Entities:   Population Interventions Outcomes