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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT03475459
Eligibility Criteria:
Inclusion Criteria:
* Subject with BMI ≥ 17.6 kg/m2 and \< 30.0 kg/m2.
* Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
* Subject who is able to comply with the study requirements during the study period.
Exclusion Criteria:
* Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
* Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
* Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
* Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
* Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
* Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.
* Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.
* Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03475459
Study Brief:
Protocol Section:
NCT03475459