Duloxetine pharmacokinetics are similar in Japanese and Caucasian subjects.
OBJECTIVE
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.


CONCLUSIONS
Duloxetine pharmacokinetics are not meaningfully different between Japanese and Caucasians.
Chan
Clark
C
Lilly-NUS Centre for Clinical Pharmacology, National University of Singapore, Singapore. clark_chan@lilly.com
Yeo
Kwee P
KP
Pan
Alan X
AX
Lim
Maggie
M
Knadler
Mary P
MP
Small
David S
DS
D000928:Antidepressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D044466:Asian People; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D006801:Humans; D013876:Thiophenes / Q000008:administration & dosage / Q000493:pharmacokinetics*; D044465:White People
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride