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, governments can therefore choose between the capsule formulation alone, the API alone, or quantities of both.
Brewster
M
M
PDMP Clinical Science, Roche Products Ltd., 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire AL7 1TW, UK. mike.brewster@roche.com
Smith
J R
JR
Dutkowski
R
R
Robson
R
R
D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007251:Influenza, Human / Q000517:prevention & control; D008297:Male; D053139:Oseltamivir / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D000998:Antiviral Agents; D002214:Capsules; D053139:Oseltamivir