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First published on April 24, 2007, doi:10.1177/0091270007299761

The Journal of Clinical Pharmacology 2007;47:689.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007299761

Article

Similarity in Pharmacokinetics of Oseltamivir and Oseltamivir Carboxylate in Japanese and Caucasian Subjects

Jerome J. Schentag 1*, George Hill 2, Tom Chu 2, and Craig R. Rayner 3

1 University at Buffalo School of Pharmacy
2 F. Hoffmann-La Roche, Inc
3 F. Hoffmann-La Roche Ltd

* To whom correspondence should be addressed. E-mail: schentag{at}buffalo.edu.


  Abstract
The pharmacokinetics of oseltamivir and oseltamivir carboxylate in healthy Japanese (n = 14) and Caucasian (n = 14) males were compared. Subjects in each ethnic group were randomized to twice-daily oral oseltamivir 75 mg, 150 mg, or placebo for 13 doses. Oseltamivir was well tolerated across doses and ethnic groups. Oseltamivir was rapidly absorbed and hydrolyzed to oseltamivir carboxylate in all subjects. The mean plasma concentration-time profiles for oseltamivir and oseltamivir carboxylate were similar in Japanese and Caucasian subjects. At steady state, there was no evidence of any ethnic difference in the individual AUC0-12 values for oseltamivir or oseltamivir carboxylate. Despite a significant difference in group mean body weight (approximately 20 kg) between the Japanese and Caucasian subjects, there was no evidence that dose-adjusted AUC0-12 and Cmax for oseltamivir carboxylate were affected by body weight or ethnicity. Day 7 trough concentrations (Cmin) for oseltamivir carboxylate markedly exceeded the IC50 (50% inhibitory concentration) against influenza A and B isolates. In conclusion, the results of this study support the use of the same dose regimens of oseltamivir in both Caucasian and Japanese subjects because of similarity in pharmacokinetics.
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