NCT04050826 - An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

December 15, 2019

Study Completion Date

July 25, 2020

Conditions

HealthyDermal Pharmacokinetic Measurements

Interventions

DRUG

Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)

Topical application

DRUG

Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)

Topical application

DRUG

Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)

Topical application

DEVICE

Dermal open flow microperfusion

"Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis.~16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site).~From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose)."

PROCEDURE

Blood sampling

1 sample will be taken pre-dose and 12 samples post-dose.

Trial Locations (1)

8010

CTU - Clinical Trials Unit, Medical University Graz, Graz

All Listed Sponsors

lead

Joanneum Research Forschungsgesellschaft mbH

OTHER