Trials / Completed
CompletedNCT00957944
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites 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 (4.5 mg/10 cm^2) From 2 Different Manufacturing Sites.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (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 sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rotigotine transdermal patch (Neupro®) | Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2009-08-13
- Last updated
- 2014-10-27
- Results posted
- 2010-09-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00957944. Inclusion in this directory is not an endorsement.