Trials Sponsors Conditions Drugs Pricing

Conditions

bioavailability trial with healthy volunteers, therapeutical indication not studied Healthy

Outcome Measures

Primary Outcomes (4)

Assessing the effect of each intervention by Area under the plasma concentration versus time curve over 24 hours (AUC0-24) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test by use of AUC0-24 of S flurbiprofen
Day 1 to Day 2 for each period
Assessing the effect of each intervention by peak plasma concentration (Cmax) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of Cmax of S flurbiprofen
Day 1 to Day 2 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last measurement time point with a concentration value above lower limit of quantitation (AUC0-tlast) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-tlast of S flurbiprofen
Day 1 to Day 4 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to infinity (AUC0-inf) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-inf of S flurbiprofen
Day 1 to Day 4 for each period

Secondary Outcomes (15)

Assessing the effect of each intervention by area under the curve over 24 hours (AUC0-24)
Day 1 to Day 2 for each period
Assessing the effect of each intervention by peak plasma concentration (Cmax)
Day 1 to Day 2 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last time point with a concentration value above lower limit of quantitation (AUC0-tlast)
Day 1 to Day 4 for each period
Assessing the effect of each intervention by area under plasma concentration versus time curve from patch application to infinity (AUC0-inf)
Day 1 to Day 4 for each period
Assessing the effect of each intervention by percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity (AUCexpol%)
Day 1 to Day 4 for each period

Study Arms (4)

TK-254RX

EXPERIMENTAL

TK-254RX will be applied with no special condition

Drug: Esflurbiprofen Topical System

TK-254RX with heat

EXPERIMENTAL

TK-254RX will be applied with moderate heat

Drug: Esflurbiprofen Topical System

TK-254RX with occlusion

EXPERIMENTAL

TK-254RX will be applied with occlusion

Drug: Esflurbiprofen Topical System

Interventions

Esflurbiprofen Topical SystemDrug

TK-254RX will be applied for one day

TK-254RXTK-254RX with exerciseTK-254RX with heatTK-254RX with occlusion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

age: 18 to 64 years (inclusive)
body-mass index (BMI): ≧18.5 kg/m² and ≦ 30.0 kg/m²

Sponsors & Collaborators

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology Unit

Mainzerhofplatz, Erfurt, 99084, Germany

Study Officials

Kenichi Nishiyama
Teikoku Seiyaku Co., Ltd.
STUDY CHAIR

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

February 28, 2025

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (15)

Study Arms (4)

TK-254RX

TK-254RX with heat

TK-254RX with occlusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

TK-254RX with exercise

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (15)

Study Arms (4)

TK-254RX

TK-254RX with heat

TK-254RX with occlusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

TK-254RX with exercise

You may not qualify if:

Data Sharing

Source records

Locations