NCT02589457已完成1 期
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUCt of Tenofovir
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
详细描述
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male volunteer in the age of 19-45
- •Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
- •Subject without a hereditary problems, chronic disease and morbid symptom
- •Subject who sign on an informed consent form willingly
排除标准
- •Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
- •Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
- •Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
- •Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
- •Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
- •Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
- •Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
- •The history of drug abuse or drug abuse showed a positive for urine drug test
- •Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
- •Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
- •Taking drugs have received any other investigational drug within 3 months prior to the first dosing
- •Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
- •Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
- •Cigarette > 10 cigarettes a day on average for recent 3 months
- •Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
- •An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
研究组 & 干预措施
CKD-390
Experimental
Tenofovir Disoproxil Fumarate
干预措施: CKD-390 (Drug)
Viread® tablet
Active Comparator
Tenofovir Disoproxil Fumarate
干预措施: Viread® tablet (Drug)
结局指标
主要结局
AUCt of Tenofovir
时间窗: 0(Pre-dose) up to 72hr
次要结局
- Physical Examination(1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day)
- t1/2β(0(Pre-dose) up to 72hr)
- Clearance/F(0(Pre-dose) up to 72hr)
- Electrocardiography(1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day)
- tmax(0(Pre-dose) up to 72hr)
- AUCinf(0(Pre-dose) up to 72hr)
- Blood pressure(1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day)
- Pulse rate(1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day)
- Temperature(1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day)
研究者
研究点 (1)
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