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This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A danoprevir | Active Comparator |
| |
| B darunavir | Placebo Comparator |
| |
| C danoprevir/darunavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | 100 mg q12h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of coadministration of darunavir (DRV), danoprevir (DNV) and ritonavir (RTV) on DRV/DNV/RTV pharmacokinetics: Area under the concentration-time curve (AUC) | approximately 2 months |
| 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 |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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| darunavir |
| Drug |
600 mg q12h |
|
| ritonavir | Drug | 100 mg q12h |
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |