HCV
Conditions
Interventions
Case series:TP-168
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are capable of understanding and complying with the protocol and have signed the informed consent form; 2. Subjects are able to complete the research according to the requirements of the test plan; 3. Subjects (including partner) are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose; 4. Aged 18-65 years male and female; 5.Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight >=50 kg for males and >=45 kg for females; 6. Physical examination and vital signs are normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Subjects allergic to the study drug (including its excipients) or subjects who are prone to allergies; 2. Smoke more than 5 cigarettes per day within three months prior to screening; 3. History of drug and/or alcohol abuse (alcohol consumption exceeding 14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine); 4. Blood donation or massive blood loss (> 450 mL) within three months prior to screening; 5. Subjects with dysphagia or with any gastrointestinal disorders (or postoperative conditions) that may affect the study drug absorption; 6. Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; 7. Subjects with major changes in diet or exercise habits recently; 8. Participation in other clinical trials within three months prior to enrollment; 9. Use of any drugs that alter liver enzyme (including, but not limited to CYP3A4 and CYP3A5)activity within 28 days prior to screening; 10. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening; 11. Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous activities or other factors that may affect the disposition of the study drug within 2 weeks prior to screening; 12. Subjects could not tolerate the standard meal (high fat and high calorie meal, two boiled eggs, a piece of butter bacon toast, a box of fried potato chips, a cup of full fat milk) (this article was only applicable to the subjects participating in the food impact study); 13. Electrocardiogram abnormalities with clinical significance; 14. The serum creatinine level during the screening period was greater than 1.5 times the normal value limit or the creatinine removal rate was 70mL/min. 15. Pregnant or lactating women; 16. Laboratory tests with clinical significance or other clinical findings that indicate clinically significant diseases not associated with HCV infection (including but not limited to gastrointestinal, renal, hepatic, neurologic, hematological, endocrine, pulmonary, psychiatric, cardiovascular diseases); 17. Any of HBsAg, anti HCV, anti HIV, or Treponema pallidum antibody were positive; 18. Acute disease or concomitant medication occurred from the screening stage to the pre study medication; 19. Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours prior to dosing; 20. Subjects with urine drug screening test positive, or with history of drug abuse in the past 5 years; 21. Subjects are not suitable to participate in the study based on the judgment of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerability;pharmacokinetics (PK); | — |
Countries
China
Contacts
Public ContactZhang/Suoming
Shanghai Tangrun Pharmaceuticals, Co. Ltd.
Outcome results
None listed