A single-center, open-label, randomized, 3-way crossover study to compare the rate and extent of Rivastigmine absorption from two different formulations of 7 day Rivastigmine transdermal systems (7-day RTS) with 24-hour Exelon® patches applied daily for 7 days in healthy male and female subjects.
Completed
- Conditions
- Dementia10012272
- Registration Number
- NL-OMON40916
- Lead Sponsor
- oven Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
healthy male or female subjects
18 - 65 years, inclusive
BMI 18.0 - 29.9 kg/m2
non-smoking
light skin color
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 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>Pharmacokinetics: plasma concentrations and PK-parameters.<br /><br>Dermal evaluations, patch adhesion, amount of adhesive residue application<br /><br>site, difficulty of patch removal, residual drug analysis.<br /><br>Safety: AE's, vital signs, ECG, clinical laboratory assessments, physical<br /><br>examination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>