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

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.

Conditions

• Healthy
• Dermal 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.

Sponsors & Collaborators

• Joanneum Research Forschungsgesellschaft mbH

  lead OTHER

Principal Investigators

• Thomas Pieber, Prof. · Medical University of Graz

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-16

Primary Completion

2019-08-28

Completion

2019-08-28

Countries

• Austria

Study Locations