A single-center, randomized, open-label, 3 way crossover study to evaluate the single and multiple dose pharmacokinetic profile of HP-5000 compared to PENNSAID® 2% in healthy volunteers

Completed

• Conditions: onstekingen; Inflammation

• Registration Number: NL-OMON42086
• Lead Sponsor: PRA Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

healthy volunteers
18 - 65 years, inclusive
18 - 30 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 30 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>The primary objective is to evaluate the single and multiple dose PK of<br /><br>Diclofenac and dimethyl sulfoxide (DMSO), obtained from two formulations of<br /><br>HP-5000 compared to PENNSAID® 2%</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To evaluate irritation, adhesion, discomfort, pain and adhesive residue of<br /><br>two formulations of HP-5000<br /><br>* To evaluate the safety and tolerability of two formulations of HP-5000</p><br>