A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 4-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF FLURBIPROFEN FOLLOWING ADMINISTRATION OF 2 FLURBIPROFEN TRANSDERMAL FORMULATIONS COMPARED TO FROBEN® 50 MG AND YAKUBAN TAPE® IN HEALTHY SUBJECTS
Completed
- Conditions
- ontstekingenInflammation
- Registration Number
- NL-OMON38802
- Lead Sponsor
- PRA International EDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
healthy male and female subjects
18-40 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking
light skin color
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>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<br /><br>analysis<br /><br>Safety: AEs, vital signs, ECG, clinical laboratory assessments, physical<br /><br>examination</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>