AIMS: 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 C(max) 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.
RCT Entities:
AIMS: 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 C(max) 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.
Authors: Thorir D Bjornsson; John A Wagner; Stephen R Donahue; Dawn Harper; Aziz Karim; Marlene S Khouri; William R Murphy; Kristin Roman; Dennis Schneck; Daryl S Sonnichsen; Dennis J Stalker; Stephen D Wise; Stuart Dombey; Caroline Loew Journal: J Clin Pharmacol Date: 2003-09 Impact factor: 3.126
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