Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy bioavailability and patch adhesion trial with healthy volunteers, therapeutic indication not studied

Outcome Measures

Primary Outcomes (3)

Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Day 5 to Day 6
Peak Plasma Concentration of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Day 5 to Day 6
Characterization of patch adhesion
Measuring patch adhesion area by percentage of visually by site staff with remaining patch adhered
Day 1 to Day 6

Secondary Outcomes (34)

Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX on Day 1
Day 1 to Day 2
Peak Plasma Concentration of S-flurbiprofen for TK-254RX on Day 1
Day 1 to Day 2
Time to reach Peak Plasma Concentration of TK-254RX after the first two patches application on Day 1
Day 1
Time before first concentration value above the lower limit of quantitation of TK-254RX after the first two patches application on Day 1
Day 1
Trough concentration of TK-254RX
24 hours, 48 hours, 72 hours, 96 hours, 120 hours after first TK-254RX application
+29 more secondary outcomes

Study Arms (2)

TK-254RX

EXPERIMENTAL

TK-254RX will be applied to left and right lower leg above ankle once daily over 5 consecutive days i.e. 10 patches will be applied totally.

Drug: Esflurbiprofen Topical System

Tablet (reference product)

EXPERIMENTAL

Tablets containing 100mg flurbiprofen will be administered three times daily (every 8 h) over 4 consecutive days i.e. 12 tablets will be administered totally.

Drug: Flurbiprofen tablet

Interventions

Esflurbiprofen Topical SystemDrug

The total of two TK-254RX per day for 5 days (one patch applied to left and right lower leg above ankle)

TK-254RX

Flurbiprofen tabletDrug

3 tablets per day for 4 days

Tablet (reference product)

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

SocraTec R&D GmbH
Othercollaborator
SocraMetrics GmbH
Industrycollaborator
HWI pharma services GmbH

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology Unit

Mainzerhofplatz 14, Erfurt, 99084, Germany

MeSH Terms

Interventions

Flurbiprofen

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

Kenichi Nishiyama
Teikoku Seiyaku Co., Ltd.
STUDY CHAIR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

January 19, 2025

First Posted

February 12, 2025

Study Start

January 21, 2025

Actual (reported)

You may not qualify if:

existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
existing or history of hypertension and/or heart failure
existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
history of gastrointestinal bleeding or perforation related to previous NSAID therapy
active, or history of ulcerative colitis, Crohn's disease, peptic ulceration or gastrointestinal haemorrhage
existing metabolic, endocrine and/or immunologic diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
diabetes mellitus
hyperlipidaemia (LDL \> 4.16 mmol/l, HDL \< 0.91 mmol/l, triglycerides \> 2.28 mmol/l, cholesterol \> 6.24 mmol/l)
history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
presence or history of acute or chronic diseases of the skin (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma), any dermatological condition or skin sensitivity which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
existing or history of bronchial asthma
known allergic reactions (e.g., bronchospasm, rhinitis, angioedema, or urticaria) to the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to constituents of the pharmaceutical preparations
history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
+27 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (34)

Study Arms (2)

TK-254RX

Tablet (reference product)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (34)

Study Arms (2)

TK-254RX

Tablet (reference product)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations