None listed
Conditions
Interventions
Drug : •Target number of subject : 32 subjects
•Study design : 2x2 cross-over
- 1 group : Reference drug 1 tablet, Test drug 1 tablet
- 2 group : Test drug 1 tablet, Reference drug 1 tablet
Sponsors
Kyung Dong Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults 19 years of age or older at the time of screening 2. BMI : 17.5 kg/m2 more than, 30.5 kg/m2 less than. Male : 55 kg more than / Female : 45 more than 3. Those who have no congenital or chronic diseases within the last 3 years and no pathological symptoms or findings as a result of medical examination 4. Those who are judged to be suitable as test subjects as a result of screening tests conducted by the investigator according to the characteristics of the drug (hematology, blood chemistry, urinalysis, virus/bacterial test, etc.), vital signs, electrocardiogram, etc. 5. Those who have the ability and willingness to participate during the entire examination period
Exclusion criteria
Exclusion criteria: 1. Those who have a history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history such as calculus, impacted tooth, wisdom tooth) 2. Those who have a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery (except simple appendicectomy, hernia surgery, and tooth extraction) that may affect drug absorption 3. A person who shows the following values ??as a result of laboratory tests : ALT or AST - twice the upper limit of the normal range 4. Those with a history of regular alcohol intake exceeding 210 g/week within 6 months of screening 5. Those who have taken other investigational drugs or bioequivalence investigational drugs within 6 months prior to the first administration of the clinical investigational drug 6. Those with a history of serious alcohol or drug abuse within 1 year of screening 7. A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of the clinical trial drug 8. Smokers who smoked more than 20 cigarettes a day within 6 months of screening 9. Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of clinical investigational drugs 10. Those who have donated whole blood within 2 months before the first administration of the clinical investigational drug, or donated component blood within 1 month 11. Persons with severe acute/chronic medical or mental conditions that may increase the risk due to administration of investigational drugs and participation in the trial or may interfere with the interpretation of trial results 12. Patients with moderate (stage3b) and severe renal impairment (eGFR <45 ml/min/1.73 m2). Kidney disease or renal insufficiency that may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and sepsis ) patient 13. Patients with congestive heart failure who require medication 14. Patients undergoing an intravenous administration of radioiodine contrast material 15. Patients with acute or chronic metabolic acidosis including type 1 diabetes mellitus, lactic acidosis, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis 16. diabetic coma 17. Patients with a history of hypersensitivity to components of investigational drugs or biguanides 18. Patients who exercise vigorously 19. Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency 20. Women who are pregnant or may be pregnant, or lactating women 21. Those who cannot consume the high-fat meal provided during this clinical tria 22. Others judged by the investigator as inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to the last quantifiable concentration, peak plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to infinity, time to reach Cmax | — |
Countries
Korea, Republic of
Contacts
Public ContactJI YOUNG JEON
Jeonbuk National University Hospital
Outcome results
None listed