Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

Criteria

Inclusion Criteria:

• Healthy White, male volunteers between 18 and 55 years of age (inclusive).

• BMI between 19 and 28 kg/m^2 (inclusive)

Exclusion Criteria:

• 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