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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference, Patch location thigh, batch 1 | Experimental | Reference, Patch location thigh, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
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| Test, Patch location thigh, batch 2 | Experimental | Test, Patch location thigh, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
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| Reference, Patch location abdomen, batch 1 | Experimental | Reference, Patch location abdomen, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
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| Test, Patch location abdomen, batch 2 | Experimental | Test, Patch location abdomen, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference, Patch location thigh, batch 1 | Drug | Reference, Patch location thigh, batch 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood and tissue diclofenac concentrations | Blood and tissue concentrations (nanograms/milliliter) of the drug diclofenac will be measured and compared between different batches of the product Flector. In addition, the two batches will be compared at different application sites, namely the abdomen and thigh. Tissue concentrations will be measured using microdialysis. | 24 hours per visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hartmut Derendorf, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| Test, Patch location thigh, batch 2 | Device | Test, Patch location thigh, batch 2. Three probes will be inserted at each visit. |
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| Reference, Patch location abdomen, batch 1 | Drug | Reference, Patch location abdomen, batch 1 |
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| Test, Patch location abdomen, batch 2 | Device | Test, Patch location abdomen, batch 2. Three probes will be inserted at each visit. |
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