NCT04592016View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

August 11, 2021

Study Completion Date

August 11, 2021

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.

Trial Locations (1)

8010

CTU - Clinical Trials Unit, Medical University Graz, Graz

All Listed Sponsors
lead

Joanneum Research Forschungsgesellschaft mbH

OTHER

NCT04592016 - Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects | Biotech Hunter | Biotech Hunter