DRKS00020911已完成1 期
Bioequivalence of Zofenopril and Nebivolol following their oral co-administration as fixed or extemporaneous combination in healthy volunteers. An open label, randomized, two periods, two sequences, cross-over study - ZOF-NEB-01
Menarini Ricerche S.p.A.0 个研究点目标入组 37 人开始时间: 2020年6月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Properly executed written informed consent form (ICF). -
- •Healthy males and females, aged 18 to 60 years, inclusive, at the screening visit. -
- •BMI between 18.5 Kg/m2 and 30 Kg/m2, inclusive, and weighs at least 50 kg at screening. -
- •Extensive metabolizers for CYP2D6. -
- •Systolic blood pressure (SBP) = 90 mmHg and diastolic blood pressure (DBP) = 60 mmHg ; PR = 60 bpm.
排除标准
- •Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs. -
- •Subjects receiving concomitant treatment with other investigational drugs or having participated in another clinical trial within the previous 6 months before their inclusion in the study (i.e., ICF signature date). -
- •Poor metabolizers for CYP2D6. -
- •Previous or current COVID-19 disease.
研究者
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