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This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | 200 mg daily (100 mg q12h) orally, Days 1-10 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 4 weeks |
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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 |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D008691 | Methadone |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
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| methadone |
| Drug |
stable maintenance therapy: 20-120 mg daily single oral morning dose |
|
| ritonavir | Drug | 200 mg daily (100 mg q12h) orally, Days 1-10 |
|
| Overland Park |
| Kansas |
| 66211 |
| United States |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |