To Evaluate the Adhesion of TK-254RX on Healthy Participants
NCT07307794 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-01-28
Summary
This study is a single-center, open-label, multiple-dose trial in healthy participants. The primary purpose of this study is to assess the adhesion of TK-254RX. Secondary purposes are to assess the safety of TK-254RX and the residual amount of the patch.
Conditions
- Healthy Participants
Interventions
- DRUG
-
Esflurbiprofen Topical System
The total of one TK-254RX per day for 3 days
Sponsors & Collaborators
-
SocraTec R&D GmbH
collaborator OTHER -
SocraMetrics GmbH
collaborator INDUSTRY -
HWI pharma services GmbH
collaborator INDUSTRY -
Clinsearch GmbH
collaborator UNKNOWN -
CRM Biometrics GmbH
collaborator INDUSTRY -
Teikoku Seiyaku Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kenichi Nishiyama · Teikoku Seiyaku Co., Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-19
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- Germany
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