ITMCTR1900002285已完成未知
Clinical pharmacology of tenofovir alafenamide clearance: a pharmacokinetic/pharmacogenetic study on plasma
onghua Hospital Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Basic Science
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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