Healthy
Conditions
Keywords
pharmacokinetics, Danoprevir/r, Ravidasvir
Brief summary
The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants
Interventions
DRUGRavidasvir
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
DRUGDanoprevir
Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
DRUGRitonavir
Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
DRUGPlacebo
Placebo
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to provide written informed consent * Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG. * If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication. * If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication. * If female, negative pregnancy test during the screening period. * Others as specified in the detailed protocol
Exclusion criteria
* History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor. * Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab * History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption. * Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method. * Others as specified in the detailed protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | 40 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) | Up to 24 weeks |
| Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state | Up to 24 days |
Outcome results
None listed