None listed
Conditions
Interventions
Drug : In 15 healthy subjects, investigational products (midazolam 2mg, dextromethorphan 30mg, caffeine 100mg, losartan 50mg, omeprazole 20mg, pitavastatin 2mg) using in vivo cocktail are single admin
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy Korean adult male aged = 19 years at the screening 2) body weight of = 50kg and within ± 20% of ideal body weight ? IBW (kg) = {height (cm) - 100} * 0.9 3) No abnormal symptom or sign, based on medical history and physical examination, 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, performed within 4 weeks prior to administration of study drug 5) Subject who understands a detailed explanation of the study protocol, voluntarily decides to participate and follow the study instructions, and signs Informed Consent
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to study drug (major ingredient or any other ingredient), or medical history of clinically significant hypersensitivity to any other drug or additives 2) Medical history that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) 3) History of gastrointestinal disease (e.g., inflammatory bowel 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 (severe infection, severe trauma, serious diarrhea or vomiting, etc.) within 4 weeks prior to the first administration of study drug 5) Systolic blood pressure = 140mmHg or < 115mmHg, diastoic blood pressure = 90mmHg or < 70mmHg in sitting position 6) History of a substance abuse 7) 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 8) 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) 9) 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 10) History of excessive alcohol abuse (> 21units/week, 1 unit = 10g = 12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period, or excessive smoking (> 10cigarettes/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) Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL(Venereal Disease Research Laboratories)) 13) Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 14) Patient with hereditary angioedema, a history of angioedema in the treatment of ACE(An angiotensin-converting-enzyme ) inhibitors or angiotensin II receptor blockers, and patient with primary hyperaldosteronism 15) Subject that is not eligible to participate at the discretion of principal investigator and study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentrations of midazolam, dextromethorphan, caffeine, losartan, omeprazole, pitavastatin and its metabolites;Urinary concentrations of dextromethorphan, losartan and its metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;vital sign;adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactHYUNJU CHO
Kyungpook National University Hospital
Outcome results
None listed