KCT0001678已完成未知
A randomized, open-label, two-way crossover study to assess the safety and pharmacokinetics of DA-2802 319 mg and Viread® 300 mg after a single oral dose in healthy male volunteers
Dong-A ST0 个研究点目标入组 36 人开始时间: 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
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Male
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 ethical drug or herbal medicines within 2 weeks before first administration or over the conter 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
研究者
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