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Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects

NCT04592016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-08-26

No results posted yet for this study

Summary

This will be a single center, open label, exploratory research study to assess the dermal pharmacokinetic (PK) profile of three marketed diclofenac products in 26 healthy volunteers using dermal open flow microperfusion (dOFM).

This clinical study aims to assess bioequivalence (BE) of three different diclofenac products.

Conditions

  • Healthy

Interventions

DRUG

Voltaren - Diclofenac sodium gel 1% (GSK, USA)

Topical application in dermal-sampling visit

DRUG

Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)

Topical application in dermal-sampling visit

DRUG

Diclofenac sodium gel 1% (Perrigo, USA)

Topical application in dermal-sampling visit

DEVICE

Dermal open flow microperfusion - Pilot

Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 24 hours post-dose.

DEVICE

Dermal open flow microperfusion - Pivotal

Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose.

PROCEDURE

Blood sampling - Pilot

1 sample is taken pre-dose and 24 samples are taken post-dose.

PROCEDURE

Blood sampling - Pivotal

1 sample is taken pre-dose and 12 samples are taken post-dose.

Sponsors & Collaborators

  • Joanneum Research Forschungsgesellschaft mbH

    lead OTHER

Principal Investigators

  • Thomas Pieber, Prof. · Medical University of Graz

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-08-11
Completion
2021-08-11

Countries

  • Austria

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 NCT04592016 on ClinicalTrials.gov