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The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

NCT03811678•Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Detailed Description

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Able to comprehend and sign the ICF voluntarily prior to initiate the study;
•Able to complete the study according to the protocol;
•Between 18 and 45 years of age（18 and 45 are inclusive）;
•Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
•Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria

•Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
•Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
•Donated blood or massive blood loss within 3 months before screening (\>450 mL）;
•Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
•Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
•Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
•Have participated in any clinical trial or taken any study drug within 3 months before dosing;
•Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
•Have taken any alcoholic products within 24 hours prior to taking the study drug

Locations (1)

the First Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

January 11, 2018

Primary Completion Date

May 29, 2018

Completion Date

May 29, 2018

Last Updated

March 19, 2020

Enrollment

120

ACTUAL participants

Conditions

Chronic Hepatitis c

Interventions

Kangdaprevir Sodium Tablet

DRUG

placebo

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

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COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

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COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection