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CompletedNCT01059903

Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches 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 (4.5mg/10cm2) Comparing Two Different Formulations

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
50 (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 two Rotigotine patches of two different formulations

Conditions

Interventions

TypeNameDescription
DRUGRotigotine transdermal patchRotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Timeline

Start date
2010-01-01
Primary completion
2010-02-01
Completion
2010-03-01
First posted
2010-02-01
Last updated
2012-05-22
Results posted
2011-03-03

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01059903. Inclusion in this directory is not an endorsement.

Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amoun (NCT01059903) · Clinical Trials Directory