Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

• Status: Completed
• Trial end date: 2016-08-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Lactams; Ritonavir

Criteria

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