Status:
COMPLETED
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Chronic Hepatitis c
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03811678
Start Date
January 11 2018
End Date
May 29 2018
Last Update
March 19 2020
Active Locations (1)
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1
the First Hospital of Jilin University
Changchun, Jilin, China, 130021