euroEPO in healthy volunteers.
- Conditions
- Stroke
- Registration Number
- RPCEC00000157
- Lead Sponsor
- Center of Molecular Immunology(CIM)/CIMAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
.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.
.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of AE (Serious, Not serious). Measuring time:daily during hospitalization. Day 14 Intensity of the AE (1 Light, 2. Moderate, 3.Severe). Measuring time:daily during hospitalization. Day 14
- Secondary Outcome Measures
Name Time Method