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Vaccine. 2006 Nov 10;24(44-46):6660-3. Epub 2006 Jun 9.

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

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1
PDMP Clinical Science, Roche Products Ltd., 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire AL7 1TW, UK. mike.brewster@roche.com

Abstract

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, governments can therefore choose between the capsule formulation alone, the API alone, or quantities of both.

PMID:
16797800
DOI:
10.1016/j.vaccine.2006.05.080
[Indexed for MEDLINE]
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