NCT06823284

To Assess the Bioavailability of TK-254RX in Comparison with Oral Flurbiprofen Tablets and the Adhesion of TK-254RX in Healthy Subjects

Characterization of Relative Bioavailability of a Newly Developed Esflurbiprofen Topical System (EFTS) in Comparison with a Marketed Oral Flurbiprofen-containing Tablet Formulation After Multiple-dose Administration Including EFTS Adhesion Assessment - a Phase I, Open-label, Randomized, 2-period, Cross-over Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Teikoku Seiyaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Esflurbiprofen Topical System	The total of two TK-254RX per day for 5 days (one patch applied to left and right lower leg above ankle)
DRUG	Flurbiprofen tablet	3 tablets per day for 4 days

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-02-12
• Completion: 2025-02-24
• First posted: 2025-02-12
• Last updated: 2025-03-11

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study