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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01889056
Eligibility Criteria:
Inclusion criteria:
* Healthy Subjects;
* Age between 18 to 35 years;
* Normal body weight (body mass index of \>= 18.5 kg/m2 \<= 24.9 kg/m2);
* Nonsmokers (\>= 1 year);
* VO2max of \<= 55 ml/kg/min for females and \<= 60 ml/kg/min for males;
Exclusion criteria:
* Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
* Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
* Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
* Persons with a hematocrit value of \> 55%;
* Persons being exposed to prolonged (\>= 5 days) high altitude (\>= 2500m above Normal Null) \<= 6 months prior the beginning of the study;
* Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
* Pregnant or breast feeding women;
* Intention to become pregnant during the course of the study;
* Lack of safe contraception;
* Treatment with other investigational products;
* Known or suspected non-compliance, drug or alcohol abuse;
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
* Participation in another study with investigational drug within the 30 days preceding and during the present study;
* Enrolment of the investigator, his/her family members, employees and other dependent persons;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01889056
Study Brief:
Protocol Section:
NCT01889056