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This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | oral doses of danoprevir |
| |
| omeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir | 1 day | |
| Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir | 1 day | |
| Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Approximately 6 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 |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| Drug |
oral doses of omeprazole |
|
| ranitidine | Drug | oral dose of ranitidine |
|
| ritonavir | Drug | oral doses of ritonavir |
|
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D009853 | Omeprazole |
| D011899 | Ranitidine |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |
| D013844 | Thiazoles |
| D001393 | Azoles |
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