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An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)

NCT04050826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-10-12

No results posted yet for this study

Summary

The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this study BE of different lidocaine/prilocaine products will be assessed and factors that influence dOFM data variability will be evaluated.

Conditions

  • Healthy
  • Dermal Pharmacokinetic Measurements

Interventions

DRUG

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

Topical application

DRUG

Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)

Topical application

DRUG

Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)

Topical application

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. 16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site). From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose).

PROCEDURE

Blood sampling

1 sample will be taken pre-dose and 12 samples post-dose.

Sponsors & Collaborators

  • Joanneum Research Forschungsgesellschaft mbH

    lead OTHER

Principal Investigators

  • Thomas Pieber, Prof. · Medical University of Graz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-12-15
Completion
2020-07-25

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050826 on ClinicalTrials.gov