Status:
COMPLETED
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body
Lead Sponsor:
UCB Pharma
Conditions:
Healthy Volunteers
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 sites.
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 :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00957944
Start Date
July 1 2009
End Date
August 1 2009
Last Update
October 27 2014
Active Locations (1)
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1
Neuss, North Rhine-Westphalia, Germany