Overview

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

Status:
Unknown status

Trial end date:
2020-02-01

Target enrollment:

Participant gender:

Summary

This will be a single center, open label, exploratory research study to assess the dermal and systemic PK of marketed products of lidocaine/prilocaine in 26 healthy participants using dermal open flow microperfusion (dOFM) and microdialysis (MD) for dermal sampling. The clinical study aims to identify potential cross-talk between the extracellular compartments of viable skin and blood circulation during (bioequivalence) BE assessments.

Phase:

N/A

Details

Lead Sponsor:

Joanneum Research Forschungsgesellschaft mbH

Treatments:

EMLA
Lidocaine
Prilocaine