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First received: March 06, 2025

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy

Study Type: INTERVENTIONAL


Official Title: 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 Healt

Brief 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.

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