Overview

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)

Status:
Completed

Trial end date:
2018-05-03

Target enrollment:

Participant gender:

Summary

The overall aim of this clinical pilot study is to develop an optimal design (e.g. dose, study duration) for the main clinical study. In the main study factors that influence dOFM data variability will be measured to develop a general BE testing method using dOFM for dermatological drug products.

Phase:

N/A

Details

Lead Sponsor:

Joanneum Research Forschungsgesellschaft mbH

Treatments:

EMLA
Lidocaine
Prilocaine