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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02342067
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent
* BMI ≥ 18 and ≤ 35 kg/m2
* No clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations, and 12-lead ECG
* Agree to comply with the study procedures and restrictions
Exclusion Criteria:
* Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant conditions as determined by the investigator
* History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy
* Serum ALT, AST or bilirubin ≥ grade 1 (ALT and AST \> ULN - 3.0 x ULN; bilirubin \> ULN - 1.5 x ULN) at screening
* Positive for HIV, HBV or HCV infection
* Use of any prescription drugs or prohibited medications within 30 days from the first dose of the study medication
* Use of alcohol-containing or caffeine-containing foods or beverages within 72 hours prior to the first dose of study medication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02342067
Study Brief:
Protocol Section:
NCT02342067