Phase
Condition
Diabetes Mellitus, Type 2
Treatment
CKD-383
Clinical Study ID
Ages 19-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy adults volunteers between the ages of 19 years to 55 years.
Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) < 30.0 kg/m2 and total bodyweight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
Following vital signs results at screening
Systolic blood pressure: 90 mmHg to 150 mmHg
Diastolic blood pressure: 50 mmHg to 100 mmHg
Individuals who is determined by investigators to be suitable as a test subject as aresult of the examination conducted at the time of screening
Individuals who agreed proper contraception during the study and did consent to notdonation of sperm 7 days after the last dose of study drug
Individuals who signed an informed consent form after being fully informed of thestudy prior to participation, including the objective and content
Exclusion
Exclusion Criteria:
Clinically significant biliary tract (such as hepatic dysfunction, liver failure,etc.), kidney (stage 3b), and severe renal impairment (eGFR <60 mL/min/1.73 m2),nervous system, immune system, respiratory system (such as pulmonary infarction,severe pulmonary dysfunction and other hypoxemia prone conditions, respiratoryfailure, etc.), urinary system, digestive system (such as diarrhea and vomiting),endocrine system, blood and tumor, cardiovascular system (acute myocardialinfarction, shock, acute and unstable heart failure, decompensated heart failure,severe heart failure, or those with a history of heart failure (such as New YorkHeart Association(NYHA) Classification 3 and 4 heart failure)
Acute or chronic metabolic acid patients with type 1 diabetes, lactic acidosis,diabetic ketoacidosis with or without a coma, and diabetic ketoacidosis patients
Patients with diabetic comas and ex-marriage
Individuals who have an acute condition that can change his or her renal function,such as dehydration, before and after surgery, severe infection, severe traumaticsystemic disorder, cardiovascular collapse (shock), sepsis, etc
Patients undergoing intravenous examination of radiodine contrast agents (e.g.,intravenous urinary tract, intravenous cholangiography, angiography, computedtomography with contrast agents, etc.)
Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenalinsufficiency
Individuals who have a history of gastrointestinal diseases (Cron's disease,ulcerative colitis, etc.) or surgery (excluding simple appendectomy or herniasurgery) that may affect the absorption of drugs
Individuals who have a history of clinically significant hypersensitivity reactionsto the main components and components of clinical trial drugs and other drugs (viguanide drugs, thiazolidinedione drugs, etc.)
Individuals who have a history of drug abuse within one year of screening or who hastested positive for a urine drug test
Pregnant women, women who may be pregnant, nursing women
Those who consumed excessive smoking or caffeine or alcohol within one month priorto the first administration of clinical trial drugs (caffeine: >5 cups/day, alcohol:male: >21 cups/week, female: >14 cups/week, tobacco: >20 cigarettes/day), or whocannot stop smoking, caffeine and alcohol consumption during each hospitalizationperiod
If the investigators determines that the drug may affect the clinical trial or thesafety of the subject by administering prescription drugs or herbal medicines within 14 days prior to the first administration of investigational product or generalmedicines including health foods and vitamin preparations within 7 days
Individuals who have taken a drug metabolase-inducing and inhibiting drug, such asbarbitals, within 30 days prior to the first administration of investigationalproduct
Individuals who had been administered investigational product from other clinicalstudy(include bioequivalence study) within the 6 months prior to the firstadministration of investigational drugs
Individuals who donated whole blood within the 8 weeks, or blood components within 2weeks or had a blood transfusion within 30 days prior to the first administration ofinvestigational drugs
Those who are deemed insufficient to participate in this clinical study byinvestigators
Study Design
Study Description
Connect with a study center
Bumin Hospital
Gangseo-gu, Seoul 07590
Korea, Republic ofSite Not Available
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