NCT00881894

Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm^2) From 2 Different Manufacturing Processes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rotigotine transdermal patch	Rotigotine 4.5mg/10cm\^2 patch applied for 24 hours

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2009-04-15
• Last updated: 2014-10-27
• Results posted: 2009-12-25

Locations

1 site across 1 country: Germany