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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02994394
Eligibility Criteria:
Inclusion Criteria:
* Body weight of at least 50.0 kg
* BMI \[body weight in kg / (height in m)2\] of at least 17.6 kg/m2 and less than 25.0 kg/m2
* Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to the start of any trial-related procedures and capable of complying with the trial procedures for this study.
Exclusion Criteria:
* Judged by the investigator,subinvestigator, or sponsor to have a clinically significant abnormality in results of the screening examination (including a notable deviation from the site's standard values) or a medical history that could place the subject at risk or affect the evaluation of drug absorption, distribution, metabolism, or excretion
* History of alcohol or drug dependence or abuse within 2 years prior to the trial
* History or current infection with hepatitis or acquired immunodeficiency syndrome (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test
* History of any severe drug allergy
* Positive results in alcohol screening test or urine drug screening test at time of screening examination or trial site admission
* Use of any other investigational medicinal product (IMP) within 120 days prior to Period 1 IMP administration
* Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
* Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
* Judgment by the investigator or subinvestigator that the subject should not participate in the study for any other reason.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT02994394
Study Brief:
Protocol Section:
NCT02994394