A study for correlation of molecular target gene polymorphism and pharmacokinetics of tenofovir alafenamide
- Conditions
- Hepatitis B
- Registration Number
- ITMCTR1900002285
- Lead Sponsor
- onghua Hospital Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
1. healthy men or women aged 18-65 years old;
2. men'weight=50kg, women'weight=45kg, BMI 19-26ks/m2;
3. Proved health by inquiring medical history, physical exam and laboratory test;
4. Participants must understand this study and agree to participate before enrolled in the study and volunteer to sign the informed consent.
1. Participants with abnormal and clinically significant results of physical exam, blood routine test, coagulation function, blood biochemistry, urine routine test, chest X-ray, electrocardiography, B ultrasound for abdomen, hepatitis B virus markers etc..Participants with active HCV antibody, HIV antibody, treponema pallidum specific antibody;
2. Participants with the following clinically significant diseases in the near 3 months (including but not limited to cardiovascular diseases, pulmonary diseases, renal diseases, gastroenterology diseases, liver diseases, metabolism diseases, hematopathy diseases, endocrinology diseases, tumors, immue diseases, neurology diseases);
3. Participants with a history of mental problems, drug abuse, drug dependence;
4. Participants with dysphagia, or those who can't follow the same diet (for example high-fat, high calorie diet intolerance);
5. Participants with allergies: such as those who are allergic to two or more drugs or foods; or those who are allergic to TAF or its ingredients;
6. Participants with drinking tea or coffee or caffeine in excess (more than 8 cups one day, 1 cup = 250mL) within the past 6 months; participants who intook any beverages or foods containing caffeine (like coffee, strong tea, chocolae etc.) within 48 hours before taking the first dose of the study;
7. Participants with positive results of breath alcohol test or often drinking (drinking more than 14 standard unit one week) before participating the study; participants with drinking more than 14 unit one week (1 unit = 360mL beer or 45mL liquor containing 40% alcohol or 150mL wine); participants with intaking any alcoholic products within 24 hours before taking the drugs of this study;
8. Participants with taking any medicine within 14 days before taking the first dose of the study, or taking medicine which has drug-drug interation with TAF within 30 days before taking the first dose of the study;
9. Participants who couldn't tolerate venipuncture;
10. Participants who participated other clinical trials within 3 monthns before taking the first dose of the study;
11. Participants who donated blood or had a massive bleeding (bleeding volume>450mL);
12. Participants who had undergone a surgery within 4 weeks before participating this study, or intend to undergo a surgery during the study period or within 2 weeks after the end of the study;
13. Participants with positive results of drug screening (morphine, tetrahydro-cannabivarinic acid, methamphetamine, dimethyl oxygen-amphetamine, ketamine);
14. Participants with a history of heaving smoking (heavy smoking means that one person who on average, smoke=3 cigarettes one day in the near 3 months);
15. Pregnant or lactating women, and men or women or their partners who plan to get pregnant during the study period or within 3 months after the end of the study, or participants who are unwilling to use non-drug contraception (like abstinence-only, using an intrauterine device, partner ligature etc.);
16. The investigators judge that the participants are not suitable to enroll in the study.
Study & Design
- Study Type
- Basic Science
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method concerntrations in plasma;genetic test;
- Secondary Outcome Measures
Name Time Method