NCT01565018

Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

Single-site, Open-label, Randomized, Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (2 mg/24 h) Comparing 2 Different Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Rotigotine PR 2.1.4	Treatment B: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.
DRUG	Rotigotine PR 2.2.1	Treatment A: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-03-28
• Last updated: 2012-07-09

Locations

1 site across 1 country: Germany