NL-OMON45504已完成4 期
Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004 - CRUSADE-1
Afdeling Apotheek0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1.Patients with sofosbuvir/velpatasvir treatment for the treatment of chronic hepatitis C 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.
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 except for conditions related to HCV.
- •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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