At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
Rotigotine transdermal patchdrug
Likely dose
Rotigotine transdermal patch 4.5mgfrom 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 (4.5mg/10cm^2) From 2 Different Manufacturing Processes
In Brief
A Phase 1 clinical trial evaluating Rotigotine transdermal patch for Healthy. Completed, enrolled 52 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 processes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
Primary CompletionNov 2008
Study CompletionDec 2008
First PostedApr 2009
TodayJul 2026
First PostedApr 15, 2009
Enrollment StartOct 1, 2008
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.2 years ago
Interventions
Rotigotine transdermal patchdrug
Rotigotine 4.5mg/10cm\^2 patch applied for 24 hours