drugset / Trial / NCT06870422
To Assess the Effect of the Special Condition on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System (EFTS) in Healthy Volunteers.
Phase 1
Completed
28 enrolled
Teikoku Seiyaku Co., Ltd.
HWI pharma services GmbH · collabSocraMetrics GmbH · collabSocraTec R&D GmbH · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-02-28
- Primary completion
- 2025-04-03
- Completion
- 2025-04-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esflurbiprofen | Small molecule | — | Topical |
Indications
No indication recorded.