6
Participants
Start Date
March 22, 2018
Primary Completion Date
April 10, 2018
Study Completion Date
May 3, 2018
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"
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
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
dOFM-System
Dermal open flow microperfusion system will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations over 24 hours
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)
HEALTH - Joanneum Research, Graz
Joanneum Research Forschungsgesellschaft mbH
OTHER