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:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT01071005
Eligibility Criteria:
Inclusion Criteria:
1. Accept the Informed Consent.
2. Subjects of research males aged 40 to 45 years;
3. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;
4. Be considered healthy, from the analysis of the clinical history and medical examination;
5. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.
Exclusion Criteria:
1. Have donated or lost 450 mL or more of blood in the three months preceding the study;
2. Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;
3. Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began;
4. Have been hospitalized for any reason, up to 8 weeks before the study;
5. Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;
6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
7. Amendments pressure of any etiology requiring pharmacological treatment;
8. Present history of myocardial infarction, angina and / or heart failure.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
45 Years
Study:
NCT01071005
Study Brief:
Protocol Section:
NCT01071005