None listed
Conditions
Interventions
Drug : Part 1 : Drug interaction evaluation of EL-1804R-2 on pharmacokinetics of EL-1804R-1
[Group A period 1] EL-1804R-1 1 tablet administered twice a daily for 5days(oral use)
[Group A period 2] E
Sponsors
Elyson Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy male subject’s age 19~50 years at screening 2) BMI 18.0-29.0kg/m2 and weight more than 50kg 3) Subject who don't have congenital or chronic diseases and have no abnormal medical examination results 4) Suitable subject who is determined by ECG and laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug at screening 5) Subjects who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by INHA University Hospital IRB 6) Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures
Exclusion criteria
Exclusion criteria: 1) Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration) 2) Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption 3) Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 4) SUbjects with a history of hypersensitivity or clinically significant hypersensitivity to drugs or other drugs containing the active ingredients or components of the IP 5) Subjects who show hypotension (Systolic Blood Pressure 2 times upper limit of normal range - Total billuribin > 2.0mg/mL - eGFR < 60 mL/min/1.73m2 7) Subjects who drink continuosly (more than 21 units/week, 1 unit = 10g = 12.5mL of pure alcohol) or who can`t drink during the study period 8) Subjects who continue to smoke (more than 10 cigarettes/day) or who can`t smoke during the hospitalization period 9) Subjects who take the medication involved in other clinical trials or bioequivalence test within 6 months before the first dose medication characters 10) Subjects who have donated whole blood within 60 days, or a component blood donation within 30 days or received blood transfustion within 30 days before the first adminitration day 11) Subjects who have taken any prescription or herbal medicine within 14 days or any OTC within 7 days before the first adminitration day 12) Subjects who have taken drug metabolizing enzyme-inducing and suppressing drugs, such as barbital drugs within 1 month before the start of the study 13) Meantal illness, drug addict 14) Subjects who have a diet (particularly grapefruit juice or its products) within 7 days prior to the first administration date that may affect the absorption, distribution, metabolism and excretion of the drug 15) Subjects who do not agree to exclude the possibility of pregnacy using a medicaly recongmized contraceptive method from the first administration of the IP to the 7 day after the last administration of the IP 16) Subjects who have clinically significant abnormalities as a result of other clinical laboratory tests or who judged the person in charge of study to be ineligible for participation in the study due to other reasons (eg., non-compliance of instruction, uncooperative attidude, etc.) 17) Positivie findings in pregnant or serum/urine hCG tests, or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt,ss, Cmax,ss | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmin,ss, Tmax,ss, Vd/Fss, CL/Fss, t1/2 | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-Heon Cho
Inha University Hospital
Outcome results
None listed