NCT01854216

Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects

Parallel Group Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Repeated Dose Treatment With Rotigotine Continuous Delivery System (5 cm^2/2.25 mg, 10 cm^2/4.5 mg, 20 cm^2/9 mg) in Japanese and Caucasian Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian female and male healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rotigotine transdermal patch 1mg / 24 hours	Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours
DRUG	Rotigotine transdermal patch 2 mg / 24 hours	Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours
DRUG	Rotigotine transdermal patch 4 mg / 24 hours	Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2013-05-15
• Last updated: 2014-10-20

Locations

1 site across 1 country: Germany