Trials / Completed
CompletedNCT03288636
Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
A Phase I Study to Assess 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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danoprevir | Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 |
| DRUG | Ritonavir | Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 |
| DRUG | Ravidasvir | Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2017-08-08
- Primary completion
- 2017-09-14
- Completion
- 2017-10-28
- First posted
- 2017-09-20
- Last updated
- 2018-01-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03288636. Inclusion in this directory is not an endorsement.