None listed
Conditions
Interventions
Drug : - Total number of subjects: 40
- Test Group: SJP003 1 tablet, Single dose
- Control Grouop: SJP003-R 1 tablet, Single dose
Sponsors
Samjin Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult male volunteers whose age is at least 19 years old and under 45 years of age at screening 2) Those with a body weight greater than 50.0 kg and a body mass index (BMI) greater than 18.0 kg / m2 and less than 30.0 kg / m2 ? BMI (kg / m 2) = body weight (kg) / {height (m)} 2 3) Those who do not have congenital or chronic disease requiring treatment and do not have pathologic symptoms or findings as a result of medical examination 4) Those who have been found to be suitable for the clinical trial subject by clinical laboratory tests, such as serum test, hematology test, blood chemistry test, urine test, urine drug test etc, and vital signs , physical examination, 12-lead ECG etc., set and performed according to the characteristics of medicines during screening 5) Those who has agreed to voluntarily participate in the clinical trial and to observe the subjects' precautions during the clinical trial period after hearing and understanding the details of the clinical trial
Exclusion criteria
Exclusion criteria: 1) Those with clinically significant current or previous history of liver, kidney, nervous system, respiratory system, endocrine system, blood or tumor, urinary, cardiovascular, musculoskeletal or mental illness. In addition, those who have the following symptoms or history ? type 1 diabetes or diabetic ketoacidosis ? diabetic pre-coma ? renal (acute kidney damage and renal dysfunction) and liver dysfunction ? heart failure ? Those at high risk of bleeding, including severe trauma and surgery 2) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 3) Those with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs 4) Those with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including dapagliflozin and other drugs (including fibrates, ketoprofen, aspirin, antibiotics, etc) 5) At the time of screening, Those whose results of 12-lead ECG show clinically significant findings including the following findings ? QTc > 450 msec ? PR interval > 200 msec ? QRS duration > 120 msec 6) When screening, Thowe whose results fo clinical laboratory tests show the following results ? AST, ALT, ALP, ?-GTP and bilirubin total exceeding twice the upper limit of normal range in clinical laboratory tests for liver function evaluation ? If serum creatinine levels exceed the normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60 mL / min / 1.73 m2 7) If you have a history of drug abuse or positive urine drug testing 8) At the time of screening, after resting for more than 3 minutes, at the vital sign measured in a sitting position, the systolic blood pressure = 150 mmHg or =90 mmHg or the diastolic blood pressure =100 mmHg or =60 mmHg, pulse = 40 times / min or = 100 times / min 9) Abnormal diets that can affect the absorption, distribution, metabolism and excretion of drugs or food supplements that can affect drug metabolism 10) Within 2 weeks before the first dosing day, those taking any ETC or herbal medicine, including cyclosporine, or within a week, those taking any OTC or vitamin, that may affect the characteristics of the clinical trial drug (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, it may be taken at the discretion of the tester.) 11) Those taking a drug-metabolizing enzyme inducing and inhibiting drug such as barbiturate drugs within 1 month before the first dosing day 12) Those who have received medication within 3 months before the first dosing day by participating in other drug clinical trials or bioequivalence test (However, the criteria for the termination of participation in other clinical trials shall be based on the last day of administration, and the next day shall be calculated as 1 day.) 13) Those who donated whole blood within 2 months before the first dosing day or component blood within 1 month, or have received blood transfusions within 1 month 14) Those drinking persistently within 6 months before the first dosing day(over 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who can't quit from 48 hours before the first dose to PSV ex. 1 cup of Beer (5 %) (250 mL) = 10 g 1 cup of Soju (20 %) (50 mL) = 8 g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf | — |
Countries
Korea, Republic of
Contacts
Public ContactMin-Kyu Park
Chungbuk National University Hospital
Outcome results
None listed