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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01981733
Eligibility Criteria:
Inclusion Criteria:
1. Be in good general health and fitness.
2. Aged between 18 and 65 years.
3. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound within 48 hours prior to commencement of the each study phase.
4. BMI between 18 and 34
5. No history or signs of drug abuse (including alcohol), licit or illicit.
6. Has not to used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the thirty (30) days preceding the study, and agrees not to use any medications during the course of the study without informing the Research Team.
7. Able to understand the Volunteer Information Sheet and signed the written Informed Consent Forms.
8. Able and willing to follow the Protocol requirements.
Exclusion Criteria:
1. Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations.
2. History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism).
3. Peripheral arterial disease (ABPI \< 0.9), varicose veins or lower limb ulceration.
4. Musculoskeletal disorders (such as pain during exercise of lower limb).
5. Recent surgery (such as abdominal, gynaecological, hip knee replacement).
6. Recent trauma to lower limb.
7. Chronic Obesity (BMI Index \>34).
8. Pregnancy.
9. Any Medication judged to be significant by the Principal Investigator (such as anticoagulants, agents with significant vasoactive activity, Oestrogen pill, 'morning-after pill' or HRT).
10. Tobacco consumption
11. History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, endocrine, neurological, dermatological, rheumatologic, metabolic (including diabetes), psychiatric, haematological (especially in relation to clotting or coagulation), or systemic disease judged to be significant.
12. A pulse rate of less than 50 beats/minute, a sitting systolic blood pressure \>160 or \<80 mmHg and/or a sitting diastolic pressure of \>90 or \<60 mmHg.
13. Any significant illness during the four (4) weeks preceding the screening period of the study.
14. Any contraindication to blood sampling.
15. Donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation.
16. Participation in any clinical study during the 8 weeks preceding the dosing period of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01981733
Study Brief:
Protocol Section:
NCT01981733