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A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of lisdexamfetamine dimesylate in Japanese and Caucasian healthy adult subjects.

James ErmerPatrick MartinMary CorcoranYumiko Matsuo
Published in: Neuropsychopharmacology reports (2019)
Pharmacokinetics were generally similar for Japanese and Caucasian subjects; the minor differences observed were likely due to bodyweight differences in the two ethnic groups. Lisdexamfetamine was generally well tolerated. Adverse events were consistent with the established safety profile of lisdexamfetamine and were similar in both ethnic groups.
Keyphrases
  • double blind
  • placebo controlled
  • clinical trial
  • phase iii
  • phase ii
  • open label
  • study protocol
  • african american
  • childhood cancer