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This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | K-285 dose/application method A |
|
| Treatment B | Experimental | K-285 dose/application method B |
|
| Treatment C | Experimental | K-285 dose/application method C |
|
| Treatment D | Active Comparator | Indomethacin capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-285 | Drug | Topical |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 | |
| Area under the plasma versus concentration time curve (AUC) | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Through study completion approximately 33 to 38 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indomethacin |
| Drug |
Capsule |
|