Active metabolite from Tamiflu registered 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 treat...

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Bibliographic Details
Published in:Vaccine 2006-11, Vol.24 (44), p.6660-6663
Main Authors: Brewster, M, Smith, J R, Dutkowski, R, Robson, R
Format: Article
Language:English
Online Access:Get full text
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Summary: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 (AUC0-infinity: [0.94-0.99]) and maximum observed plasma concentrations (max: [0.93-1.08]). Thus, the two formulations were bioequivalent for oseltamivir carboxylate. For pandemic stockpiling of Tamiflu registered , governments can therefore choose between the capsule formulation alone, the API alone, or quantities of both.
ISSN:0264-410X
DOI:10.1016/j.vaccine.2006.05.080