clinical trial · NCT06870422
To Assess the Effect of the Special Condition on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System (EFTS) in Healthy Volunteers.
Teikoku Seiyaku Co., Ltd.·phase1·completed·n = 28
HealthyEsflurbiprofen Topical System
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.
started
Feb 28, 2025
primary completion
Apr 3, 2025
completion
Apr 14, 2025
last updated
Apr 22, 2025
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 Healthy Volunteers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol