None listed
Conditions
Interventions
Drug : This clinical trial consists of three single-group studies for each diabetes drug in order to explore the interaction between Ojeok-son and three diabetic drugs, respectively. The tests are con
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male between 19 and 45 years of age at the time screening tested 2) Bodyweight between 50 and 90 kg, and BMI between 18.0-29.0 kg/m^2 ? BMI = (weight [kg])/(height [m])^2 3) Subject who decided to participate voluntarily and agreed to abide by the precautions after hearing and fully understanding the detailed explanation of this clinical trial 4) Subject who was determined to be healthy by the investigator based on the screening test(physical exam, laboratory test, inquiry, and others)
Exclusion criteria
Exclusion criteria: 1) History of hepatic, gastrointestinal, circulatory, renal, respiratory, endocrine, neurologic, immunologic, hematologic, psychiatric system, neoplasm, or drug abuse 2) History of hypersensitivity against the investigational product or drug belonging to the same class as the investigational product 3) Contraindication to investigational product (Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, etc.) 4) History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or surgery (except appendicectomy or hernia repair) that may affect the absorption of investigational product 5) History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or surgery (except appendicectomy or hernia repair) that may affect the absorption of investigational product ? At the vital sign check, systolic blood pressure under 90 mmHg or over 150 mmHg, or diastolic blood pressure under 60 mmHg or over 100 mmHg ? Hepatic insufficiency (liver enzymes in the blood (AST and ALT) over 1.5 times of upper limit of normal) ? Renal insufficiency (as evidenced by an estimated eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m^2 based on the MDRD(Modification of Diet in Renal Disease) formula) ? Subject who has results positive or exceed the reference range in serological test (HBs antigen, HCV antibody, HIV antibody, and RPR test) 6) Subject who has used during the specified period or be unable to stop using food or drugs as follows ? Subject who has continuously taken drugs and foods known as CYP enzyme inducers or inhibitors within 4 weeks before the first dose ? Subject who has any prescription or traditional medication within 2 weeks or over-the-counter medication within 1 week before first investigational drug (IP) administration (but, in the investigator's judgment, when other conditions are suitable, the subject can participate in this trial.) ? Subject who has taken drugs that induce or inhibit drug, such as barbiturates, metabolizing enzymes within 1 month, or has taken drugs that may interfere with the test within 10 days before the first dose ? Subject who has taken or be unable to stop taking grapefruit or food containing grapefruit from 72 hours before the first dose to the end of the study ? Subject who has taken or be unable to stop taking caffeine or food containing caffeine from 72 hours before the first dose to the end of the study ? Subject who has continuously drunken within 6 months before the first dose or be unable to stop drinking from the day of informed consent to the end of the study 7) Participation in other clinical trials within 6 months before the first dose (The end date of previous clinical trial is one day after the last administration day) 8) From the day of informed consent to 2 weeks after the last dose, subject, subject' spouse, or subject' partner are expecting to pregnant or are unable to practice acceptable methods of contraception and even if not expecting (e.g., oral contraceptive, contraceptive injection, hormonal or non-hormonal contraceptive implant, intrauterine device and intrauterine contraceptive device) 9) Whole blood donation within 2 months, apheresis blood donation within 1 month, or blood transfusion within 1 month before the first dose 10) Subjects who be unable to stop vigorous exercising exceeding the daily routine from 72 hours before the first dose to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC (Part 1: metformin, Part 2: glimepiride, Part 3: dapagliflozin, respectively);Gmax, AUCG (Part 1, 2) / cumulative urine glucose 24h (Part 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac biomarker;Hepatic biomarker;Kidney biomarker;Pharmcogenomics | — |
Countries
Korea, Republic of
Contacts
Public ContactSooyoung Lee
Kyung Hee University Hospital
Outcome results
None listed