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This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapendavir 300 mg tablet | Experimental | Vapendavir 300 mg tablet single dose with up to 7 day washout period followed by two vapendavir 132 mg capsules single dose |
|
| Two Vapendavir 132 mg capsules | Experimental | Two Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapendavir 300 mg tablet | Drug | tablet - single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure profile of a single dose of a vapendavir 300 mg tablet compared to the exposure profile following a single dose of two 132 mg vapendavir capsules | PK and statatistical analyses will be performed to determine the Primary Outcome Measure | maximum up to 46 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Matson, M.D. | Prism Research, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Saint Paul | Minnesota | 55101 | United States |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Vapendavir 132 mg capsules |
| Drug |
2 capsules - single dose |
|