Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

Launched by UCB PHARMA · Aug 12, 2009

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • healthy, white, male volunteers between 18 and 55 years of age (inclusive)
• • BMI between 19 and 28 kg/m² (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
• • thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites