drugset / Trial / NCT06823284
To Assess the Bioavailability of TK-254RX in Comparison with Oral Flurbiprofen Tablets and the Adhesion of TK-254RX in Healthy Subjects
Phase 1
Completed
26 enrolled
Teikoku Seiyaku Co., Ltd.
HWI pharma services GmbH · collabSocraMetrics GmbH · collabSocraTec R&D GmbH · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation in healthy volunteers in a 2-period, 2- sequence-cross-over design and evaluate adhesion of TK-254RX. Secondary purpose is to assess safety of TK-254RX and residual amount of the patch.
Timeline
- Start
- 2025-01-21
- Primary completion
- 2025-02-12
- Completion
- 2025-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esflurbiprofen | Small molecule | — | Topical |
| Subject | Flurbiprofen | Small molecule | 100 mg | Oral |
Indications
No indication recorded.