None listed
Conditions
Interventions
None listed
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) A healthy adult male aged 19 to 50 years old at the time of the screening test (2) Those whose body mass index is 18.5 ~ 25 kg / m2 (3) A person who is judged to be eligible as a subject through a medical examination (clinical examination, vital sign, 12-lead ECG, blood test, urinalysis, etc.) (4) Prior to participating in the examination, applicants who have fully explained the purpose of the examination, the contents of the examination, * Target person extraction method: recruitment by non-probabilistic method
Exclusion criteria
Exclusion criteria: (1) A cardiovascular disease (acute heart failure, aortic stenosis, etc.), a respiratory disease, a kidney disease, an endocrine disease or a blood disease which may affect the absorption, distribution, metabolism and excretion of a drug, (Hemorrhagic wheezing), gastrointestinal (peptic ulcer) and central nervous system disease, mental illness, or meningitis (2) A person who has donated whole blood within 60 days, donated a component blood within 30 days, or confirmed to have received a blood transfusion within 30 days of the clinical trial drug administration (3) If there is a history of continuous drug abuse (central nervous system drugs such as special sleeping pills, opiates, or antipsychotic drugs) within one year of screening (4) Those who have a history of hypersensitivity or clinically significant hypersensitivity to the components of the clinical trial drug or other nitrate or other drugs (5) When the average vital signs measured three times at 1 minute intervals after resting for more than 5 minutes at the screening, the systolic blood pressure was less than 110 mmHg, the arterial blood pressure was more than 160 mmHg, the diastolic blood pressure was less than 70 mmHg, or more than 110 mmHg (6) In the case of participating in other clinical trials within 90 days of the initiation of the trial and taking the drug for clinical trial (provided that the biological dosage is 3 months, based on a longer period considering the half life) (7) Continually ingest caffeine (> 5 cups / day coffee, 1250 cc / day tea, 1250 cc / day cola), continuous smoking (10 cfu / day) or continuous drinking (> 210 g / week) If the drug can not be withdrawn until 2 days before the first administration of the clinical trial drug and the pharmacokinetic evaluation is completed (8) Clinical trial medication If you take the prescribed medication or herbal medicine within 14 days before the first administration day, or take the general medication within 7 days, depending on the researcher's judgment, the medication may affect the test, If it is determined that it may affect safety (9) Pregnant women (10) Patient whom the researcher deems inappropriate for participation in the clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The adsorption amount of the drug according to each material | — |
Secondary
| Measure | Time frame |
|---|---|
| The adsorption amount of the drug according to each material | — |
Countries
Korea, Republic of
Contacts
Public Contacthyojin byon
Yonsei University
Outcome results
None listed