NCT03279146已完成1 期
Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects
ContraVir Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state
研究概览
简要总结
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects
详细描述
This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age:18-55 Capable of giving written informed consent Capable of completing study requirements
排除标准
- •History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days
研究组 & 干预措施
Regimen A
Active Comparator
Immediate release tablet Tenofovir exalidex (TXL)
干预措施: Tenofovir exalidex (TXL) (Drug)
Regimen B
Experimental
New Formulation 1 Tenofovir exalidex (TXL)
干预措施: Tenofovir exalidex (TXL) (Drug)
Regimen C
Experimental
New formulation 2 Tenofovir exalidex (TXL)
干预措施: Tenofovir exalidex (TXL) (Drug)
结局指标
主要结局
Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state
时间窗: up to four days post dose
Measuring Cmax, the peak plasma concentration
次要结局
未报告次要终点
研究者
研究点 (1)
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