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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001001-24 | EudraCT Number |
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This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: STV capsule (after high fat meal) | Active Comparator |
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| B: STV capsule (fasted state) | Active Comparator |
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| C: STV tablet (after high fat meal) | Experimental |
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| D: STV tablet (fasted state) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| setrobuvir | Drug | 200 mg capsule formulation, single oral dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability: Cmax/area under the concentration-time curve (AUC) | Pre-dose and up to 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C000592794 | setrobuvir |
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| setrobuvir | Drug | 200 mg tablet formulation, single oral dose |
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