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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02479204
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
* Women of childbearing potential must have a negative pregnancy test and they must use reliable methods of contraception
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests
Exclusion Criteria:
* Pregnant or lactating women
* Any contraindication to the study drugs
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* Any clinically significant abnormalities in laboratory tests, vital signs, ECG variables and pulmonary variables
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT02479204
Study Brief:
Protocol Section:
NCT02479204