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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01692158
Eligibility Criteria:
Inclusion Criteria:
* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 18 and 55 years, clinically healthy;
* BMI between 18.5 and 30;
Exclusion Criteria:
* Participation in clinical trials in the 12 months preceding the trial;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hemoglobin \< 13 g/dL;
* Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
* Use of medications that interact with enoxaparin;
* History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
* History of coagulopathy and bleeding diathesis;
* Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
* Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);
* Absolute platelet count below 100 x 109 / L;
* History of chronic bleeding;
* History of acute haemorrhage in the past 30 days;
* History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
* History of allergy or Steven Johnson disease;
* Current or previous history (under 12 months) use of illicit drugs and tobacco;
* History of alcohol abuse, current or previous (within 12 months);
* At the discretion of the Principal Investigator of the study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01692158
Study Brief:
Protocol Section:
NCT01692158