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 mbH1 site in 1 country22 target enrollmentOctober 8, 2020

InterventionsVoltaren - Diclofenac sodium gel 1% (GSK, USA)Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)Dermal open flow microperfusion - Pilot Blood sampling - Pilot Diclofenac sodium gel 1% (Perrigo, USA)Dermal open flow microperfusion - Pivotal Blood sampling - Pivotal

DrugsVoltaren - Diclofenac sodium gel 1% (GSK, USA)Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)Diclofenac sodium gel 1% (Perrigo, USA)

Overview

Phase: Not Applicable
Intervention: Voltaren - Diclofenac sodium gel 1% (GSK, USA)
Conditions: Healthy
Sponsor: Joanneum Research Forschungsgesellschaft mbH
Enrollment: 22
Locations: 1
Primary Endpoint: Area under the dermal concentration versus time curve for diclofenac (pilot study: 6 participants, pivotal study: 20 participants)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 8, 2020

End Date

August 11, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Joanneum Research Forschungsgesellschaft mbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, adult volunteers of age 18 to 65 years (both inclusive).
•Males or non-pregnant, non-breast feeding females using adequate contraceptive methods or abstinence.
•Able to read, understand and sign the written informed consent form.
•Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion Criteria

•Social habits
•Smoker who is not willing to refrain from smoking during the in-house visit.
•History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
•Medications: Use of any medications other than hormonal contraceptive, hormone replacement therapy or routine vitamins within the 7 days or 5 half-life periods whichever is longer prior to the initial dose of study medication.
•Diseases: Presence of any clinically relevant acute or chronic disease, which in the investigator´s opinion might jeopardise subject's safety, evaluation of results or compliance with the protocol.
•Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
•Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator.
•Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
•Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
•Positive results to the test for hepatitis B antigen or hepatitis C antibodies.

Arms & Interventions

Pilot Study

Dermal-sampling visit: Measurement of dermal pharmacokinetic (PK) parameter (AUC, Cmax) of diclofenac using dermal open flow microperfusion (dOFM) after topical application of diclofenac sodium products in 6 participants. Additionally systemic appearance of diclofenac is measured by blood sampling.

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

Pilot Study

Intervention: Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)

Pilot Study

Intervention: Dermal open flow microperfusion - Pilot