None listed
Conditions
Interventions
Drug : • Target number of subjects : 80 subjects (Part A : 40subjects, Part B : 40subjects)
• Study design : 2x2 Cross-over
• Test group : KD4004 1 tablet, Xigduo XR 10/1000mg 1 tablet
• Reference gr
Sponsors
Kyung Dong Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion 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
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 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 10 cfu / day) who are unable to abstain during the clinical trial from 3 days prior to the clinical trial, or those who are unable to continue drinking during the trial (21units / week, 1unit = 10g = 12.5mL of pure alcohol) 12) Those with a history of substance abuse 13) From the screening date until 30 days after the last clinical trial drug administration, appropriate double-pregnancy or medically acceptable contraceptive methods (including intrauterine devices with proven pregnancy failure rates, physical contraceptive methods and spermicide) Use, vasectomy, tubal resection / ligation, hysterectomy, etc.) 14) Women who are pregnant or who may be pregnant and breastfeeding 15) Any person taking any OTC medicines or herbal medicines within 2 weeks of the first day of medication or who has taken any OTC medication within 1 week will be subject to the judgment of the examiner that the medication will affect the test or the safety of the subject When it is judged to be influential 16) Those who participated in other clinical trials within 3 months before the first dosing day (The time of ending the previous clinical test is set as the last dosing day.) 17) Those who donated whole blood within 2 months before the first administration day, or those who donated blood within 1 month 18) Those who received blood transfusions within one month before the first dose 19) Those who have had abnormal diets that can affect the absorption, distribution, metabolism and excretion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From 0 h to the last quantifiable concentration Area under the concentration-time curve, peak serum concentration;The area under the concentration-time curve from time 0 to infinity, Cmax arrival time | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2, CL/F | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungRan Yoon
Kyungpook National University
Outcome results
None listed