KCT0004026
Completed
未知
A study to evaluate the pharmacokinetics and safety of KD4004 after oral administration in healthy adult volunteers
Kyung Dong Pharmaceutical0 sites80 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Kyung Dong Pharmaceutical
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adults who are at least 19 years old at the time of screening
- •2\) Those who have a body mass index (BMI) of 18\.0 kg / m2 or more and 29\.9 kg / m2 or less at screening
- •3\) Patients with no congenital or chronic disease and no medically symptomatic findings
- •4\) Those who are determined to be eligible for the results of 12\-lead electrocardiogram and clinical tests such as serum test, hematology test, blood chemistry test, urine test, etc., set by the doctor in charge within 3 weeks prior to administration of the drug for clinical trial
- •5\) ? ????? ?? ??? ??? ?? ??? ??? ?, ??? ??? ???? ????? ????? ?? ??? ?
Exclusion Criteria
- •1\) Persons who have a history of hypersensitivity reactions or other clinically significant hypersensitivity to other drugs or additives in the main components or components of clinical trial medicines
- •2\) There is a clinically significant liver / biliary system, kidney, respiratory system, digestive system, blood • tumor, endocrine system, cardiovascular system, nervous system, skin and urinary system, mental illness, A person with
- •3\) Diabetic patients (diabetic patients with history of ketoacidosis), diabetic ketoacidosis, lactic acidosis, pre\-diabetic comatose patients or those with a history of diabetes
- •4\) Patients who received intravenous administration of radiation iodine contrast material (intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast media, etc.) within one week before the first dosing day
- •5\) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose\-galactose malabsorption
- •6\) In a vital sign measured in a sitting position, a person having a numerical value included in any one of the criteria of systolic blood pressure \= 140 mmHg or \<90 mmHg, diastolic blood pressure \=95 mmHg, or \<60 mmHg, pulse rate\> 100 times / minute
- •7\) Patients with active liver disease or those with AST, ALT, or total bilirubin greater than 1\.5 times the upper limit of normal range
- •8\) Creatinine clearance \<80 mL / min (creatinine clearance is calculated by Cockcroft\-Gault formula using serum creatinine)
- •9\) Patients who have gastrointestinal diseases (Crohn's disease, active peptic ulcer, etc.) that may affect the absorption of clinical trial medications or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- •10\) Any person who has suffered a major injury within 4 weeks prior to the first dose, or who has undergone surgical procedures and who has suspected acute illness (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
Outcomes
Primary Outcomes
Not specified
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