A single-center, open-label, randomized, 3-way crossover study to evaluate the pharmacokinetic profile and tolerability of Flurbiprofen following administration of two Flurbiprofen transdermal formulations compared to Yakuban Tape® in healthy subjects

Completed

• Conditions: ontstekingen, reumatoïde artritis, spieraandoeningen; Inflammation; 10023213

• Registration Number: NL-OMON40944
• Lead Sponsor: oven Pharmaceuticals, Inc.

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 subjects
18-65 years, inclusive
BMI: 18.0-30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, 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 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>To evaluate the PK profile of flurbiprofen following the administration of two<br /><br>different formulations of FTS (35 mg flurbiprofen / 70 cm2).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare the PK profile of flurbiprofen following a single 24-hour<br /><br>application of FTS (35 mg flurbiprofen / 70 cm2) to that following a<br /><br>twice-a-day application of Yakuban Tape® (20 mg flurbiprofen / 70 cm2).<br /><br>To assess the adhesion, discomfort, irritation and adhesive residue of the<br /><br>transdermal systems.<br /><br>To assess the safety and tolerability of FTS and Yakuban Tape®.</p><br>