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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT02081950
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female volunteer between 18 and 55 years of age.
* Female subject of child bearing potential with a negative pregnancy test at the Screening Visit and willing to use 2 effective methods of contraception from Day 1 until 3 months afterwards.
* Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
Exclusion Criteria:
* Female subject with weight \< 45 kg or male subject with weight \< 57 kg.
* Subject with clinically relevant abnormal physical findings which could interfere with the objective of the study.
* Subject with clinically relevant abnormal laboratory values indicative of physical illness; Hemoglobin \<13 g/dL; Absolute platelet count below 100 x 109/L.
* Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.
* Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. In addition, history or presence of: alcoholism or drug abuse within the past year; clotting disorders; gastric or duodenal ulcers; hypertension; retinopathy; deep venous thrombosis; pulmonary embolism; GI bleeding.
* Subject with any clinically significant illness within 4 weeks prior to dosing.
* Subject with recent use of NSAID and/or aspirin (within 4 weeks of first dose) or the use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days of the first dose. No subject may take any antibiotic agent known to interfere with intestinal microflora within 30 days of the first dose. Subjects with any medical condition requiring regular treatment with prescription drugs.
* Subject with recent severe trauma, surgery (eye surgery), and/or lumbar puncture;
* Female subject who was pregnant or lactating.
* Subject who was a vegetarian.
* Subject who, through completion of the study, would have donated in excess of 500 mL of blood and/or plasma within the previous 3 months.
* Subject who regularly consumed excessive amounts of alcohol.
* Subject who consumed excessive amount of caffeine (\> 5 cups of coffee or equivalent per day).
* Subject who was a smoker (cigarettes and tobacco-related products), or ex-smoker who had smoked in the 3 months preceding the study. Subjects were tested for urinary cotinine at screening.
* Subjects who could not tolerate venepuncture.
* Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
* Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02081950
Study Brief:
Protocol Section:
NCT02081950