The aim of this study is to compare and evaluate the pharmacokinetic properties and safety of oral administration of KD4002
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007757
- Lead Sponsor
- Kyung Dong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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. Others judged by the investigator as inappropriate to participate in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve from time 0 to the last quantifiable concentration, peak plasma concentration;Area under the concentration-time curve from time 0 to infinity, time to reach Cmax
- Secondary Outcome Measures
Name Time Method Teneligliptin, metformin : AUCinf, Tmax, t1/2, CL/F, Vd/;Safety evaluation