NCT02557594已完成1 期
A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose 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
- 36
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC)last of Tenofovir
研究概览
简要总结
This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose 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
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 50, healthy male subjects(at screening)
- •Body weight over 55kg, BMI between 18.0 - 27.0
- •Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
排除标准
- •Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)
- •Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- •Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread
- •Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics
- •exceed 1.5 times the normal range of AST, ALT at screening test before randomization
- •history of drug abuse, or a positive urine drug screen
- •having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
- •Participation in any other clinical trial involving investigational drugs within 3 months
- •Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
- •Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- •Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)
- •Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods
- •Volunteers who are not using adequate contraception methods or have a pregnancy plan
- •volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study
- •any condition that, in the view of the investigator, would interfere with study participation
研究组 & 干预措施
Viread → DA-2802
Experimental
- Viread 300mg(Tenofovir disoproxil fumarate)
- DA-2802 319mg(Tenofovir disoproxil orotate)
干预措施: DA-2802 319mg (Drug)
Viread → DA-2802
Experimental
- Viread 300mg(Tenofovir disoproxil fumarate)
- DA-2802 319mg(Tenofovir disoproxil orotate)
干预措施: Viread 300mg (Drug)
DA-2802 → Viread
Experimental
- Viread 300mg(Tenofovir disoproxil fumarate)
- DA-2802 319mg(Tenofovir disoproxil orotate)
干预措施: Viread 300mg (Drug)
DA-2802 → Viread
Experimental
- Viread 300mg(Tenofovir disoproxil fumarate)
- DA-2802 319mg(Tenofovir disoproxil orotate)
干预措施: DA-2802 319mg (Drug)
结局指标
主要结局
Area Under Curve(AUC)last of Tenofovir
时间窗: 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Maximum of concentration(Cmax) of Tenofovir
时间窗: 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
次要结局
- Terminal half-life(t1/2) of Tenofovir(0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose)
- Time of maximum concentration(Tmax) of Tenofovir(0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose)
- Apparent Clearance(CL/F) of Tenofovir(0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose)
- Area Under Curve(AUC)inf of Tenofovir(0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose)
研究者
研究点 (1)
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