NCT06870422

To Assess the Effect of the Special Condition on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System (EFTS) in Healthy Volunteers.

A Randomized, Four-way Change-over Study to Evaluate the Effect of Moderate Heat, Occlusion, and Moderate Exceise on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Teikoku Seiyaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, single-dose trial performed in a randomized, four-way, change-over design in healthy volunteers. The primary purpose of this study is to evaluate the effect of moderate heat, occlusion, and moderate exercise on pharmacokinetics. The secondary purpose is to characterize the effect of special conditions on the bioavailability and to evaluate patch adhesion and safety of TK-254RX and a residual amount of the patch.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Esflurbiprofen Topical System	TK-254RX will be applied for one day

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-04-03
• Completion: 2025-04-14
• First posted: 2025-03-11
• Last updated: 2025-04-22

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study