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S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet

NCT04505787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-10-22

No results posted yet for this study

Summary

Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as its active pharmaceutical ingredient.

The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing 100 mg racemic flurbiprofen in a 1:1 ratio). Characterisation will be performed under steady state conditions in order to bridge the available safety information on the basis of the comparison of maximum observed systemic exposure by means of AUC0-24h,ss,P vs. AUC0-24,ss,T and Cmax,ss,P vs. Cmax,ss,T of S-flurbiprofen.

Conditions

  • Comparative Bioavailability

Interventions

DRUG

Esflurbiprofen hydrogel patch 165 mg (EFHP)

patch application with PK blood sampling

DRUG

Froben 100 mg comprimidos revestidos

tablet administration with PK blood sampling

Sponsors & Collaborators

  • Teikoku Seiyaku Co., Ltd.

    collaborator INDUSTRY

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Principal Investigators

  • Frank Donath, MD · SocraTec R&D GmbH Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2020-09-09
Completion
2020-09-24
FDA Drug
Yes

Countries

  • Germany

Study Locations

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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 NCT04505787 on ClinicalTrials.gov