A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-398 in Healthy Volunteers Under Fasting Conditions
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-398 in Healthy Volunteers Under Fasting Conditions
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-398 in healthy volunteers under fasting conditions
Inclusion Criteria:
Healthy adults age≥19 years and age<55 years at the time of screening
Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
* BMI = Weight(kg)/ Height(m)2
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
Individuals with the ability and willingness to participate the entire study period
Exclusion Criteria:
Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption.
Individuals with the following laboratory test results at screening:
• ALT or AST > 2x the upper limit of the normal range
History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
Following vital signs results at screening
- Sitting systolic blood pressure ≥ 140 mmHg or < 90 mmHg and/or sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs
Subject had severe heart failure(NYHA class 1, 2, 3, 4)
Patients with hepatopathy
Patients with diabetic ketogenic acidosis, diabetic comas and ex-coma, type 1 diabetes.
Before and after surgery, severe infections, severe trauma.
Patients with edema
Subject had renal impairment(eGFR < 60 mL/min/1.73 m²)
Subject who is a pregnant or nursing woman
Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects who were deemed inappropriate to participate in the study by the investigator