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Bioequivalence of Topical Acyclovir in Healthy Volunteers

NCT02711267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-03-17

No results posted yet for this study

Summary

The overall aim of this clinical study is to investigate the ability of dermal open flow microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in the skin of healthy volunteers.

Conditions

  • Dermatologic Disorders

Interventions

DRUG

5% Zovirax® cream

(manufactured by GlaxoSmithKline Pharma in Canada, distributed in the USA by Valeant Pharmaceuticals North America LCC, Bridgewater,NJ 08807)

DRUG

5% Aciclostad cream

(STADA Arzneimittel GmbH, Vienna, Austria)

DRUG

5% Aciclovir cream 1A Pharma

(1A Pharma GmbH, Vienna, Austria)

DRUG

5% Zovirax Cold Sore Cream

(GlaxoSmithKline Consumer Health Care, Brendfort, UK; Marketing authorization holder: Beeham Group PLC, Brendfort, UK)

DRUG

5% Zovirax® cream (Austria)

(GlaxoSmithKline Pharma GmbH, Vienna, Austria)

PROCEDURE

OFM

Sampling method for interstitial fluid

DEVICE

OFM Probe

Sampling probe used during OFM

DEVICE

OFM Pump

Pump used to operate OFM probes

Sponsors & Collaborators

  • Joanneum Research Forschungsgesellschaft mbH

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Thomas R Pieber, MD · Medical University of Graz

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

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 NCT02711267 on ClinicalTrials.gov