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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT02147704
Eligibility Criteria:
Inclusion Criteria:
* The subject who has a body weight of 50 to 90 kg and has a body mass index (BMI) of 18.5 to 29.9 kg/m2.
* The subject who voluntarily agrees to participate in the study by written informed consent.
Exclusion Criteria:
* The subject who has a history of hypersensitivity reaction to fimasartan or other drugs.
* The subject who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* The subject who has a history of any history or evidence of any clinically significant hepatic, urologic, gastrointestinal, neurologic, pulmonary, endocrinologic, musculoskeletal, hematologic, oncologic, psychiatric, cardiovascular disease.
* The subject who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis and etc.) or surgery (except simple appendectomy or hernia repair) which can significantly affect the absorption of the study drug.
* The subject who has a systolic blood pressure (SBP) =\<90 or \>=160 mmHg, diastolic blood pressure (DBP) =\<60 or \>=90 mmHg, and/or pulse rate (PR) \>=100.
* The subject who has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 x upper limit of normal.
* The subject who has a history of drug abuse.
* The subject who has participated in any interventional clinical study within 60 days prior to the study drug administration.
* The subject who has used any prescribed or traditional oriental drugs within 2 weeks, or nonprescribed drugs within 1 week prior to the study administration.
* The subject who has donated 1 unit (450 mL) of blood or more within 60 days, or received a transfusion of any blood or blood products or donated plasma within 60 days prior to the study administration.
* The subject who has eaten unusual diet which can affect the absorption, distribution, metabolism, elimination processes of the study drug.
* The subject who is a heavy smoker (\>10 cigarettes per day) within 3 months prior to Screening and unable to quit smoking during study period.
* The subject who consumes more than 21 unit/week of alcohols or unable to stop drinking during study period.
* The subjects who consumes excessive amount of grapefruit containing beverage of food and unable to quit eating or drinking them.
* The subjects who consumes excessive amount of caffeine containing beverage of food and unable to quit eating or drinking them.
* The subject who has a positive result for hepatitis C antibodies, hepatitis B surface antigen,
* The subject who are unable to perform the present clinical study, judged by investigators.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT02147704
Study Brief:
Protocol Section:
NCT02147704