NCT04592016

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Joanneum Research Forschungsgesellschaft mbH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The clinical study is divided into a pilot and a pivotal study. The pilot study will involve 6 healthy adult volunteers. The pilot study aims to develop the optimal study design for the pivotal study by defining the dose of the reference product (diclofenac sodium gel 1%) and by evaluating the absence of significant systemic cross-talk (systemic redistribution) and lateral diffusion (cross-talk between adjacent treatment sites), which could increase background drug levels in the dermis that might confound the discrimination of dermal PK profiles between different products. Additionally, the suitability of a non-equivalent test product to serve as negative control for BE relative to the reference product will be evaluated. The pivotal study will involve 20 healthy adult volunteers. In each volunteer the dermal PK profile of three different diclofenac products will be assessed in 6 topical treatment sites using dermal open flow microperfusion (dOFM), where the diclofenac penetration will be measured from baseline to 12 h post-dose. BE of the reference product against a generic test product (positive control) and against a non-equivalent test product (negative control) will be evaluated.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-08-11
• Completion: 2021-08-11
• First posted: 2020-10-19
• Last updated: 2022-08-26

Locations

1 site across 1 country: Austria