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Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products

NCT01592019 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-12-13

No results posted yet for this study

Summary

The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. The small device is placed directly in the fatty tissue and samples are taken at specific times. The investigators will determine whether site of application affects the availability of the drug.

Conditions

  • Bioequivalence

Interventions

DRUG

Reference, Patch location thigh, batch 1

Reference, Patch location thigh, batch 1

DEVICE

Test, Patch location thigh, batch 2

Test, Patch location thigh, batch 2. Three probes will be inserted at each visit.

DRUG

Reference, Patch location abdomen, batch 1

Reference, Patch location abdomen, batch 1

DEVICE

Test, Patch location abdomen, batch 2

Test, Patch location abdomen, batch 2. Three probes will be inserted at each visit.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Florida

    lead OTHER

Principal Investigators

  • Hartmut Derendorf, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

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 NCT01592019 on ClinicalTrials.gov