A study to assess the endogenous metabolic alterations and pharmacokinetic·pharmacodynamic characteristics after oral administrations of dapagliflozin in healthy and obese adult volunteers
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007864
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1. Healthy adults who are 19 years of age or older at the time of the screening test.
2. At the time of the screening test, Those with a body mass index (BMI) of 18.0 kg/m2 or more and less than 25.0 kg/m2 (healthy adult applicants) or those with a body mass index of 30.0 kg/m2 or more (obese adult applicants).
3. A person who has no congenital or chronic disease and has no pathological symptoms or findings as a result of medical examination.
4. A person who is determined to be suitable subject as a result of clinical experiment performance tests that set/conducted by the doctor accroding to the characteristics of the investigational product within 4 weeks prior to administration of the investigational product such as hematology tests, hemochemical tests, urinary tests and 12-lead electrocardiogram tests and serum tests.
5. A person who has heard and fully understood the detailed description of this study and has agreed in writing to voluntarily decide to participate and comply with the cautions
1. A person who has a history of clinically significant hypersensitivity to the main ingredient or component of Investigational product or to other drugs or additives.
2. A person who has a diseases or history of diseases such as clinically significant liver/biliary system, kidney, respiratory system, digestive system, blood/tumor, endocrine system, immune system, cardiovascular system, nervous system, skin and urology system, mental illness, otolaryngeal system, musculoskeletal system, etc.
3. A person who is patient or has history of diabetes, diabetic ketoacidosis, lactic acidosis, diabetic pre-coma.
4. A person who has been tested for intravenous administration of radioiodine contrast material within 1 week prior to the first administration date (intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast medium, etc.).
5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
6. A person who active liver disease or those with AST, ALT, and total bilirubin exceeding 1.5 times the upper limit of the normal range.
7. A person who Creatinine clearance < 80 mL/min (creatinine clearance is calculated by the Cockcroft-Gault formula using serum creatinine).
8. A person with positive serological test results (HBsAg, HCV Ab, HIV Ag/Ab, VDRL).
9. A person who has gastrointestinal tract system diseases (Crohn's disease, active peptic ulcer, etc.) that can affect the absorption of Investiogational Product or has undergone gastrointestinal tract system surgery (however, except simple appendectomy or hernia surgery).
10. A person who has suffered serious injuries or undergone surgical procedures within 4 weeks prior to the first administration, and A person who has symptoms suspected of having an acute disease (severe infection, severe trauma, severe diarrhea, vomiting, etc.).
11. A person who continuously excessively drink (exceed 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or cannot abstain from alcohol during the study period, or A person who smoke excessively (tobacco > 10 cigarettes/day).
12. A person with a history of drug abuse.
13. From the screening date up to the 30th day after the last investigational product administration A person who is unable to perform by oneself, spouse, partner appropriate medically recognized double contraception or medically acceptable contraception(intrauterine device with proven pregnancy failure rate, simultaneous use of physical barrier contraception and spermicide, vasectomy, tubectomy, tubal ligation, hysterectomy, etc.).
14. Women and lactating women who is pregnant or likely to be pregnant.
15. Among someone who has taken any prescription drugs or herbal medicines within 2 weeks before the first administration date or who has taken any over-the-counter medicines (OTC) within 1 week, Depending on the researcher's judgment, in case of the medication he or she taken affects the study or the safety of the subject.
16. A person who participated in other clinical trials within 6 months before the first administration of investigational product(However, at the end of the previous clinical trial is determined by the last date of administration.)
17. A person who has donated whole blood within 2 months or component blood within 1 month before the first administration date, or has received a transfusion.
18. A person who have had an abnormal diet that may affect the absorption, distribution, me
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Metabolites;Pharmacokinetics;Pharmacodynamics
- Secondary Outcome Measures
Name Time Method Safety