EUCTR2016-003941-27-NL进行中（未招募）1 期
Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004 - CRUSADE-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6.
- •2.Patient is at least 18 at the day of screening.
- •3.Patient is able and willing to sign the Informed Consent Form.
- •4.Patient is able and willing to follow protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Pregnant female (as confirmed by an hCG test performed 4 weeks before Day 84) or breast-feeding female.
- •2.Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •3.Inability to understand the nature and extent of the study and the procedures required.
- •4.Clinically relevant low hemoglobin concentration at screening judged by the patient’s own physician
研究者
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