None listed
Conditions
Interventions
Drug : single group, sumatran 50mg 1capsule, oral administration, once
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy male subject aged =19 years at screening 2) Body weight of = 50 kg and within ± 20% of ideal body weight ? IBW (kg) = height (cm) - 100} * 0.9 3) Subject that is considered eligible for medical history and physical examination conducted in accordance with the study protocol, with no congenital or chronic disease 4) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, prior to administration of study drug (results : normal or no clinical significant) 5) wonen who are not pregnant 6) Subjects who understand a detailed explanation of the study protocol, voluntarily decide to participate and follow the study instructions, and sign Informed Consent
Exclusion criteria
Exclusion criteria: 1) Medical History of clinically significant hypersensitivity to study drug (major ingredient or any other ingredient) 2) congenital or chronic disease, pathological symptoms or findings of medical examination 3) History of gastrointestinal disease (e.g., Crohn’s disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy) 4) History of major injury, surgical operation, or suspected symptom of acute illness within 4 weeks prior to the first administration of study drug 5) history of drug abuse 6) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator 7) Participation in any other study within 3 months prior to the first administration of study drug (The completion date of previous study is the day of the last administration of study drug) 8) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug 9) History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period 10) excessive smoking (>20 cigarettes/day) 11) Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice = 1L /day within 7 days prior to administration of study drug) 12) Subject that is not eligible to participate at the discretion of study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast, Cmax, Tmax, t1/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| SAFETY EVALUATION-physical examination,vital sign, clinical laboratory test & ECG, AE(subjective,objective) | — |
Countries
Korea, Republic of
Contacts
Public ContactJun Woo
Kyungpook National University Hospital
Outcome results
None listed