An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

NACompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 22, 2018

Primary Completion Date

April 10, 2018

Study Completion Date

May 3, 2018

Conditions
Dermatology/Skin - OtherDermal Pharmacokinetic Measurements
Interventions
OTHER

Dermal pharmacokinetic measurement

"* Each subject will have 9 test sites: 4 on the left thigh, 4 on the right thigh, 1 on the arm~* Each test site receives 2 dOFM probes~* Dosing:~ * 2 test sites: 15 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)~ * 2 test sites: 10 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)~ * 2 test sites: 5 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)~ * 1 test site: 10 mg/cm² Oraqix® gel (2.5% lidocaine, 2.5% prilocaine, Dentsply Pharmaceutical Inc., US/Dentsply DETRY GmbH, Germany)~ * 2 test sites: untreated test site~* ISF sampling: 24 hours post-dose~* Blood sampling: 7 samples post-dose"

DRUG

Lidocaine and prilocaine cream

lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US) will be applied to 6 test sites per subject

DRUG

Oraqix® gel

Oraqix® gel (2.5% lidocaine, 2.5% prilocaine, Dentsply Pharmaceutical Inc., US/Dentsply DETRY GmbH, Germany) will be applied to 1 test site per subject

DEVICE

dOFM-System

Dermal open flow microperfusion system will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations over 24 hours

PROCEDURE

Blood sampling

8 blood samples will be collected in order to assess systemic lidocaine/prilocaine concentrations pre-dose (1 sample) and 24 hours post dose (7 samples)

Trial Locations (1)

8010

HEALTH - Joanneum Research, Graz

All Listed Sponsors
lead

Joanneum Research Forschungsgesellschaft mbH

OTHER

NCT03613207 - An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM) | Biotech Hunter | Biotech Hunter