RPCEC00000157已完成1 期
Evaluation of the safety of the nasal administration of NeuroEPO in healthy volunteers.
Center of Molecular Immunology(CIM)/CIMAB0 个研究点目标入组 30 人开始时间: 2013年6月10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
- 30
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 trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 40 years(—)
- 性别
- All
入选标准
- •.Voluntary nature of the subject through the signing of informed consent. .Aged between 18 and 40 years. .Not be organic or psychological disease according to the interrogation. .Conclude successfully the physical examination.
排除标准
- •.Women who are pregnant or are breastfeeding.Will be the participants in the study pregnancy test. .Volunteers with hypersensitivity to the active substance(recombinant human erythropoietin)or to any of the active substances that make up the product. .Volunteers with rhinitis of any kind. .Volunteers with the nasal septum deviation. .Volunteers with mental disorders. .Alcoholic volunteers.Will be considered alcoholics those people with more than a quarter of a bottle of rum consumption or 1 bottle of wine or three beers with one frequency greater than 2 times per week. .Presence of chronic non-communicable diseases como asma, hipertensión, diabetes mellitus o cardiopatía isquémica. .Consumption of any drug in the period between the 15 days prior to the start of the trial or during the trial. .Volunteer who has undergone more surgery during the six months prior to the start of the trial. .Having made a donation of blood during the three months prior to the start of the trial. .Participating in a clinical trial during the six months prior to the start of the study.
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