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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT02077803
Eligibility Criteria:
Inclusion Criteria:
* Must sign an informed consent document indicating they understand the purpose of the study and procedures
* Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
* Must have a body weight of not less than 50 kg
* Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
* Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
Exclusion Criteria:
* History of or current clinically significant medical illness
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to heparin or history of heparin induced thrombocytopenia
* Donated blood or blood products or had substantial loss of blood within 3 months before screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02077803
Study Brief:
Protocol Section:
NCT02077803