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

• Status: Completed
• Trial end date: 2018-05-29
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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