Duloxetine pharmacokinetics are similar in Japanese and Caucasian subjects

What is already known about this subject

• The pharmacokinetics of duloxetine have been assessed in a number of clinical studies.

What this study adds

• Duloxetine pharmacokinetics in Japanese or Caucasian subjects is not meaningfully different after single or multiple doses of duloxetine.

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.

DOI: 10.1111/j.1365-2125.2006.02770.x

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