NCT01675024

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine after single and multiple doses of Rotigotine transdermal patch, and also to investigate the safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rotigotine, Period 1	Formulation: transdermal Dosage: 2 mg / 24 hours once at Day 2 Frequency: once every 24 hours Duration: from Day 1 to Day 3
DRUG	Rotigotine, Period 2	Formulation: transdermal Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12 Frequency: once every 24 hours Duration: from Day 1 to Day 3

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-08-29
• Last updated: 2012-12-04

Locations

1 site across 1 country: China