KCT0007864
Not yet recruiting
未知
A study to assess the endogenous metabolic alterations and pharmacokinetic·pharmacodynamic characteristics after oral administrations of dapagliflozin in healthy and obese adult volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Kyungpook National University Hospital
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.).
Outcomes
Primary Outcomes
Not specified
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