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This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Regimen A | Experimental | FV-100 400mg OD as a single dose fasted (>/= 8 hours) |
|
| Treatment Regimen B | Experimental | FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FV-100 | Drug | Subjects will be randomized to one of two treatment sequences: AB or BA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir | Measuring the Cmax, Tmax and AUC for FV-100 pk profile | Two weeks |
| The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir | Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir | Two weeks |
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Inclusion Criteria:
Exclusion Criteria:(must NOT meet the following)
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| ID | Term |
|---|---|
| C526677 | FV-100 |
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