Status:
COMPLETED
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects
Lead Sponsor:
UCB BIOSCIENCES GmbH
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian female and male healthy subjects.
Eligibility Criteria
Inclusion
- Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, ECG, hematology, clinical chemistry, urinalysis)
- Subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg/m²
- Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese
Exclusion
- Subjects (females) without medically adequate contraception or on lactation or pregnant women. Subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment
- Subject has a history of chronic alcohol or drug abuse
- Subject has a consumption of more than 20 g of alcohol/day (amount corresponds to 0.5 l of beer/day or 0.25 l of wine/day or 3 glasses (à 2 cl) of liquor/day)
- Subject has a clinically relevant allergy
- Subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication
- Subject has any clinically significant abnormality in physical examination
- Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm
- Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg
- Subject has an atopic or eczematous dermatitis and/or an active skin disease or skin tumors
- Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01854216
Start Date
December 1 2002
End Date
March 1 2003
Last Update
October 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
1
Neuss, Germany