Patch adhesiveness study
Completed
- Conditions
- ziekte van Parkinson en rustelood been syndroomParkinson disease and Restless Legs Syndrome
- Registration Number
- NL-OMON36856
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
Healthy males and females
18-55 years
BMI 19-28 incl
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adhesiveness: the average adhesiveness score of 2 days of 24-hour patch<br /><br>application as rated by the investigator<br /><br><br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>skin assessments, physical examination, the C-SSRS</p><br>
- Secondary Outcome Measures
Name Time Method <p>Patch adhesiveness over 24 hours of patch application and immediately after<br /><br>patch application </p><br>