NCT02070796

Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations

Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese 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: 50 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm\^2) Rotigotine transdermal patches in Chinese subjects.

Detailed description

Bioequivalence will be concluded if the 90 % Confidence Intervals (CIs) for the ratio Treatment A/Treatment B are fully included in the acceptance range from 0.8-1.25 for AUC(0-t) and AUC, and within the acceptance range from 0.7 to 1.43 for Cmax.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rotigotine PR2.2.1	Treatment A: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.
DRUG	Rotigotine PR2.1.1	Treatment B: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-02-25
• Last updated: 2014-07-29

Locations

1 site across 1 country: China