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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT03706469
Eligibility Criteria:
Inclusion Criteria:
1\. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2), at Screening.
Exclusion Criteria:
1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
3. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
5. Donation of blood or significant blood loss within 56 days prior to the first dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03706469
Study Brief:
Protocol Section:
NCT03706469