Status:
COMPLETED
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Lead Sponsor:
UCB Pharma
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 processe...
Eligibility Criteria
Inclusion
- Healthy White, male volunteers between 18 and 55 years of age (inclusive).
- BMI between 19 and 28 kg/m² (inclusive).
Exclusion
- Previous participation in a clinical study with rotigotine
- History or current condition of epilepsy and/or seizures.
- Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity.
- History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis.
- History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease.
- Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations.
- Positive HIV, hepatitis B or C test or positive alcohol or drug test.
- Relevant hepatic or renal dysfunction
- Intake of medication that might interfere with the test drug within 2 weeks prior to dosing.
- Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00881894
Start Date
October 1 2008
End Date
December 1 2008
Last Update
October 27 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neuss, North Rhine-Westphalia, Germany