Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393
Study Details
Study Description
Brief Summary
Study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
A randomized, open-label, single dose, crossover study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1group Period 1 - A single dose of 2 tablets(CKD-393) under fed condition. Period 2 - A single dose of 2 tablets(CKD-393) under fasting condition. |
Drug: CKD-393
PO, QD
|
| Experimental: 2group Period 1 - A single dose of 2 tablets(CKD-393) under fasting condition. Period 2 - A single dose of 2 tablets(CKD-393) under fed condition. |
Drug: CKD-393
PO, QD
|
Outcome Measures
Primary Outcome Measures
- AUCt of CKD-393 [0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours]
AUCt: Area under the curve from dosing to time
- Cmax of CKD-393 [0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours]
Cmax: Peak plasma drug concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adults volunteers aged between 19 and 55 years old at the time of screening
-
Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 to 30.5 kg/m2
-
Those who have no congenital diseases or chronic diseases within 3years and have no abnormal symptoms or findings.
-
Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, urinalysis, serology etc) and 12-lead ECG results at screening.
-
Those who voluntarily signed an informed consent form approved by the Institutional Review Board(IRB) of clinical trial site and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content of the clinical trial.
-
Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 1 month after the last administration of investigational product.
-
Those who have the ability and willingness to participate during the entire clinical trial.
Exclusion Criteria:
- Those who have a medical evidence or history (excluding a dental history of periodontal surgery, impacted wisdom tooth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic, or history of immune diseases.
1-1) Patients with severe heart failure or with a history of heart failure (patients with Ⅰ, Ⅱ, Ⅲ, Ⅳ heart condition on NYHA classification.).
1-2) Patients with hepatic impairment. 1-3) Patients with type 1 diabetes mellitus, diabetic coma, precoma, or diabetic ketoacidosis.
1-4) Before and after surgery, patients with severe infections, patients with severe trauma.
1-5) Patients with edema. 1-6) Patients with moderate to severe renal impairment (eGFR<60ml/min/1.73 m2). 1-7) Acute conditions that can affect renal function, such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis 1-8) Patients with tests intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast agent, etc) 1-9) Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency.
1-10) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
-
Those who have a medical history of gastrointestinal diseases (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.
-
Those who have the following laboratory test result at screening
- ALT or AST > 2x the upper limit of the normal range.
-
Those who have a history of regular alcohol consumption exceeding 210 g/week within 6 months prior to screening (1drink (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).
-
Those who smoked more than 20 cigarettes per day within 6 months prior to screening.
-
Those who had taken investigational product(s) from other clinical trial or bioequivalence trial within 6 months prior to the first administration of investigational product.
-
Those with the following vital signs upon screening.
- sitting systolic blood pressure ≥140 mmHg or <90 mmHg or sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
-
Those who have a drug(s) abuse or significant alcohol history within 1 year before the first administration of investigational product.
-
Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product.
-
Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
-
Those who donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 4 weeks prior to the first dose of the investigational product.
-
Those who with severe acute/chronic medical or mental conditions that may pose greater risk to subjects or hinder accurate analysis of clinical trial results from the administration of investigational products and/or participation in clinical trials.
-
Those who with hypersensitivity to investigational products, the major ingredients and components of investigational products.
-
Pregnant or childbearing potential and lactating women.
-
Those who can't ingest the high-fat meal provided during this clinical trial.
-
Those who were deemed inappropriate to participate in the clinical trial by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Guro Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
- Principal Investigator: Hyewon Chung, M.D., Ph.D., Korea University Guro Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A98_06FDI2125