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

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.

journal_name

Vaccine

journal_title

Vaccine

authors

Brewster M,Smith JR,Dutkowski R,Robson R

doi

10.1016/j.vaccine.2006.05.080

subject

Has Abstract

pub_date

2006-11-10 00:00:00

pages

6660-3

issue

44-46

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(06)00639-6

journal_volume

24

pub_type

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