Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNV + r reference | Active Comparator |
| |
| DNV/r fixed dose combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | Fixed dose combination tablet with ritonavir, single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC) | Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 | |
| Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC) | Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 2 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
Not provided
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| danoprevir | Drug | Reference tablet, single oral dose |
|
| ritonavir | Drug | Fixed dose combination tablet with danoprevir, single oral dose |
|
| ritonavir | Drug | Reference tablet, single oral dose |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |