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The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PK Group (Danoprevir,Ritonavir) | Experimental | Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13; |
|
| Placebo Group | Placebo Comparator | ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danoprevir | Drug | Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 40 days | |
| Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) | Up to 16 days | |
| Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state | Up to 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. | Study Director |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Ritonavir | Drug | Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 |
|
|
| Placebo | Drug | ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13 |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |