NCT03813030 - An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 16, 2019

Primary Completion Date

August 28, 2019

Study Completion Date

August 28, 2019

Conditions

HealthyDermal Pharmacokinetic Measurement

Interventions

PROCEDURE

Intravenous infusion of lidocaine

Lidocaine is intravenously administered in clearance visit and blood samples are taken to calculate individual clearance of each participant.

DRUG

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

Topical application in dermal-sampling visit

DRUG

"Lidocorit 2%-Ampullen (Gebro Pharma Gesellschaft mit beschränkter Haftung, Austria)"

Intravenous infusion in clearance visit

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.~Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose"

DEVICE

Dermal Microdialysis

"Dermal microdialysis will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations in the dermis.~Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose"

PROCEDURE

Blood sampling in dermal sampling visit

1 sample is taken pre-dose and 12 samples are taken post-dose.

PROCEDURE

Blood sampling in clearance visit

1 sample is taken pre-dose, 3 samples during intravenous infusion and 13 samples post-dose.

Trial Locations (1)

8010

Clinical Research Center, Medical University Graz, Graz

All Listed Sponsors

lead

Joanneum Research Forschungsgesellschaft mbH

OTHER