Active metabolite from Tamiflu® solution is bioequivalent to that from capsule delivery in healthy volunteers:: A cross-over, randomised, open-label study

The bioavailability of oseltamivir phosphate and oseltamivir carboxylate were assessed in healthy volunteers when delivered as a solution of the active pharmaceutical ingredient (API) compared with the commercial capsule formulation. The 90% confidence intervals (CIs) for the ratios of the two treatments (capsule versus solution) were within the reference region [0.80-1.25] for area under the curve (AUC(0-infinity): [0.94-0.99]) and maximum observed plasma concentrations (C-max: [0.93-1.08]). Thus, the two formulations were bioequivalent for oseltamivir carboxylate. For pandemic stockpiling of Tamiflu (R), governments can therefore choose between the capsule formulation alone, the API alone, or quantities of both. (c) 2006 Elsevier Ltd. All rights reserved.