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To Assess the Effect of the Special Condition on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System (EFTS) in Healthy Volunteers.

NCT06870422 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-04-22

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Esflurbiprofen Topical System

TK-254RX will be applied for one day

Sponsors & Collaborators

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • HWI pharma services GmbH

    collaborator INDUSTRY

  • Teikoku Seiyaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenichi Nishiyama · Teikoku Seiyaku Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-04-03
Completion
2025-04-14
FDA Drug
Yes

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06870422 on ClinicalTrials.gov