NCT01964573

Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose applications of the Rotigotine transdermal patch in healthy young male and female Korean subjects to be submitted to MFDS for new drug application approval.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Day 1-3: 2 mg patch once daily Day 4-6: 4 mg patch once daily
OTHER	Placebo	Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches. Frequency: Day 1-3: 2 mg patch once daily Day 4-6: 4 mg patch once daily

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2013-10-17
• Last updated: 2014-10-20

Locations

1 site across 1 country: South Korea