Trials / Completed
CompletedNCT02230904
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- UCB BIOSCIENCES GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm\^2, under the assumption that both patch formulations show similar adhesiveness properties.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rotigotine (Test product PR 2.3.1) | * Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal |
| DRUG | Rotigotine (Reference product PR 2.1.1) | * Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2014-11-01
- Completion
- 2014-12-01
- First posted
- 2014-09-03
- Last updated
- 2015-11-02
- Results posted
- 2015-11-02
Locations
11 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02230904. Inclusion in this directory is not an endorsement.