NCT01592019

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

Use of Dermal Microdialysis to Evaluate the Effect of Skin Properties and Application Site on the Topical Bioequivalence of Diclofenac: The Main Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-05-04
• Last updated: 2012-12-13

Locations

1 site across 1 country: United States