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

NCT ID: NCT03020134

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2016-08-22

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Keywords

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pharmacokinetics Danoprevir/r Ravidasvir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PKGroup(Ravidasvir/Danoprevir/Ritonavir)

Ravidasvir + Danoprevir/ Ritonavir

Group Type EXPERIMENTAL

Ravidasvir

Intervention Type DRUG

Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23

Danoprevir

Intervention Type DRUG

Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Ritonavir

Intervention Type DRUG

Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Placebo Group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Ravidasvir

Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23

Intervention Type DRUG

Danoprevir

Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Intervention Type DRUG

Ritonavir

Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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ASC16(RDV) ASC08 (DNV) RTV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huoling Tang, PhD

Role: STUDY_DIRECTOR

Ascletis Pharmaceuticals Co., Ltd.

Other Identifiers

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ASC162002

Identifier Type: -

Identifier Source: org_study_id