Phase
Condition
Stress
Vascular Diseases
Williams Syndrome
Treatment
N/AClinical Study ID
Ages > 19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A healthy adult aged over 19 at the time of screening
Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
Subject who has no congenital or chronic disease within the last 3 years and nomedical symptoms or signs as a result of medical examination
Suitable subject who is determined at the time of screening by examiners according tothe characteristics of the medicine such as hematology test, blood chemistry test,urine test, virus / bacteriological test, vital signs, electrocardiogram test
Subject who signed the written consent form approved by Chonbuk National UniversityHospital IRB to participate in this study with full understanding of the purpose andcontents of the examination prior to participation of the clinical trial
Subject who has the ability and willingness to participate in the clinical trial
Exclusion
Exclusion Criteria:
Subject who has (or has histories of) clinically significant blood, kidney, endocrine,respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological orallergic diseases(except for asymptomatic seasonal allergy at the time ofadministration) or evidence(except for simple dental history such as dental calculus,impacted tooth, wisdom tooth, etc.)
Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagusstenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitissurgery or hernia surgery or tooth extraction surgery) that may affect the absorptionof drug
Subject who shows the following values as a result of laboratory tests
*ALT or AST > 2 times upper limit of normal range
Subject who has a history of regular alcohol consumption in excess of 210 g/weekwithin 6 months of screening
Subject who smokes more than one pack of cigarette a day within 6 months of screening
Subject who took other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug
Subject who conform to the specific items below
systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolicblood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
Severe bradycardia (less than 50 beats/minute)
Subject who has significant alcohol abuse or drug abuse within a year of screening
Subject who took drugs which are known as disturbing drug metabolism within 30 daysprior to the first administration of clinical trial drug.
Subject who uses any of other drugs, including over-the-counter medications andprescription medications within 10 days prior to first administration of clinicaltrial drug.
Subject who donated whole blood within 2 months prior to first administration ofclinical trial drug or blood components within 1 month prior to first administrationof clinical trial drug
Subject who is hypersensitive to the components of a clinical trial drug or clinicaltrial drug itself.
Subject who does not consent to reliable contraception during the entire period ofclinical trial and until 7th day of administration of clinical trial drug.
Subject who is not able to consume high-fat meal provided during the clinical trial
Any other subject who is decided by investigators to be ineligible in clinical trial
Study Design
Study Description
Connect with a study center
Chonbuk National University Hospital
Jeonju,
Korea, Republic ofActive - Recruiting

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