Pharmacokinetic properties and tolerability of rotigotine transdermal patch after repeated-dose application in healthy korean volunteers

Clinical Therapeutics
Bo-Hyung KimWilli Cawello

Abstract

Rotigotine, a nonergolinic dopamine receptor agonist, is a once-daily transdermal patch developed for the treatment of Parkinson's disease and restless legs syndrome. The objective of the present study was to determine the pharmacokinetic characteristics and tolerability of rotigotine transdermal patch after repeated-dose application in healthy male and female Korean subjects. In this randomized, double-blind, placebo-controlled, repeated-dose study, subjects were randomly assigned to receive either rotigotine or placebo (ratio, 20 rotigotine to 4 placebo, per sex). Rotigotine patches were applied once daily at a dose of 2 mg/24 h on days 1 to 3, followed by 4 mg/24 h on days 4 to 6. Serial blood and urine samples were collected on days 1 to 9 for the determination of the concentrations of rotigotine and its metabolites. Tolerability was evaluated by adverse events determined using physical examination, including vital signs with orthostatic measurements; ECG; and clinical laboratory testing. A total of 48 healthy Korean subjects were enrolled (24 men, 24 women; mean age, 24 years). Approximately 50% of the total drug content was delivered within 24 hours. The mean plasma concentration of unconjugated rotigotine increased propo...Continue Reading

References

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Apr 18, 2007·Neurology·Peter A LeWittUNKNOWN SP 650 Study Group
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Dec 20, 2008·British Journal of Clinical Pharmacology·Marina BraunRolf Horstmann
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Jul 25, 2009·Journal of Clinical Pharmacology·Marina BraunRolf Horstmann
Jun 29, 2011·British Journal of Clinical Pharmacology·Willi CawelloMarina Braun

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