Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch

Summary

STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers TEST DRUG / INVESTIGATIONAL PRODUCT: Rotigotine Transdermal System, 1 mg/24 hr INDICATION STUDIED: Bioequivalence - Irritation and Sensitization STUDY DESIGN: * Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study * One-half (½) of the test patch and one-half (½) of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase

Timeline

Start

2013-08

Primary completion

2013-10

Completion

2013-10

Drugs

Indications

No indication recorded.