A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, FOUR-WAY-CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF THE HP-5000 PATCH (DICLOFENAC SODIUM TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 24-HOUR APPLICATION COMPARED TO FLECTOR® AND VOLTAREN® 100 MG IN HEALTHY ADULT MALE AND FEMALE SUBJECTS UNDER FASTING CONDITIONS

Completed

• Conditions: ontstekingen; inflammation

• Registration Number: NL-OMON37576
• Lead Sponsor: oven Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

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: diclofenac 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: AEs, vital signs, ECG, clinical laboratory assessments, physical<br /><br>examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>