At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
rotigotine transdermal patch (Neupro®)drug
Likely dose
rotigotine transdermal patch (Neupro®) 4.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating rotigotine transdermal patch (Neupro®) for Healthy Volunteers. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
Primary CompletionAug 2009
First PostedAug 2009
TodayJul 2026
First PostedAug 13, 2009
Enrollment StartJul 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago
Interventions
rotigotine transdermal patch (Neupro®)drug
Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours