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This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI-668 capsule followed by tablet | Experimental | On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered |
|
| PPI-668 tablet followed by capsule | Experimental | On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI-668 capsule | Drug |
| ||
| PPI-668 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| PPI-668 area under the curve from time zero to infinity (AUC 0-inf) | Days 1 - 8 | |
| PPI-668 maximum observed plasma concentration (Cmax) | Days 1 - 8 | |
| PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t) | Days 1 - 8 |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with adverse events | Days 1 - 8 | |
| number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels | Days 1 - 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Brown, MD | Presidio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo Clinical Research Center | Buffalo | New York | 14202 | United States |
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| ID | Term |
|---|---|
| C000621711 | ravidasvir |
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| Drug |
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