Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT01392612
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers.
* Age between 18-40 years.
* Body mass index 17-27.
* Normal haemoglobin levels (Hb males 13.5-18g/dL, females 12-16g/dL).
* Reticulocyte count within reference values (32-110G/L).
* S-Iron within reference values (males 60-150µg/dl, females 40-150µg/dL).
* Serum ferritin within reference values (females 10-140µg/L, males 20-280µg/L).
* CRP within reference values (\<1,0mg/dL).
* Signed informed consent.
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant for this study.
* Woman of child bearing potential must agree to practice effective barrier methods for birth control.
Exclusion Criteria:
* Smoking.
* Regular use of medication and food supplements containing iron.
* Abuse of alcoholic beverages and drugs.
* Participation in a clinical trial in the 3 weeks preceding the study.
* Foreseen inability to attend to scheduled study visits.
* Deficiency in folate (\<3.4nmol/L) or vitamin B12 (\<118pmol/L) (reevaluation after supplementation is allowed).
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia. AST and/or ALAT \> 3xULN (AST males \> 105U/L, females \>93U/; ALAT males \> 135U/L, females \>102U/L).
* Symptoms of a clinically relevant illness during 3 weeks prior the first study day.
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of erythropoietin.
* Blood donation during the previous 3 weeks prior to the first study day.
* History of hypersensitivity erythropoietin.
* Pregnancy or lactation period.
* Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01392612
Study Brief:
Protocol Section:
NCT01392612