CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Voltaren - Diclofenac sodium gel 1% (GSK, USA) +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04592016
NCT04592016N/ACompleted
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A Single Center, Open-label, Clinical Study to Evaluate the Ability of Dermal Open Flow Microperfusion (dOFM) for Bioequivalence Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects

Joanneum Research Forschungsgesellschaft mbH·interventional·Posted Oct 19, 2020·Updated Aug 26, 2022

In Brief

A clinical study evaluating Voltaren - Diclofenac sodium gel 1% (GSK, USA), Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA), and 5 other interventions for Healthy. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartOct 8, 2020
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.7 years ago

Interventions

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

Topical application in dermal-sampling visit

Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)drug

Topical application in dermal-sampling visit

Diclofenac sodium gel 1% (Perrigo, USA)drug

Topical application in dermal-sampling visit

Dermal open flow microperfusion - Pilotdevice

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.

Dermal open flow microperfusion - Pivotaldevice

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.

Blood sampling - Pilotprocedure

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

Blood sampling - Pivotalprocedure

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