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The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | PKGroup: Ravidasvir + Danoprevir/ Ritonavir |
|
| Placebo | Placebo Comparator | Placebo Group: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danoprevir | Drug | Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events | 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Zhejiang province | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34252301 | Derived | Wu G, Zhou H, Wu J, Lv D, Wu L, Zhai Y, Lin M, Wu JJ, Shentu J. Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0060021. doi: 10.1128/AAC.00600-21. Epub 2021 Jul 12. |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| C000621711 | ravidasvir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Ritonavir | Drug | Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 |
|
| Ravidasvir | Drug | Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23 |
|
|
| Placebo | Drug | Placebo |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |