To compare single- and multiple-dose duloxetine pharmacokinetics between healthy Japanese and Caucasians.Methods
Twenty-four subjects of each race were given single oral doses of duloxetine (20, 40 and 60 mg) in a randomized, double-blind study. Another 20 subjects of each race received 20, 40 mg or placebo (2: 2: 1) twice-daily for 5 days.Results
Following single doses, the mean duloxetine Cmax and AUC were approximately 20% greater in Japanese. This difference could be explained by the 15% lower average body weight in Japanese. Similar results were observed following multiple dosing.Conclusion
Duloxetine pharmacokinetics are not meaningfully different between Japanese and Caucasians.