Clinical trial NCT05113693: Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393 in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Objective

- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index (BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
3. Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
6. Those who agree to contraception until the 1 month after last administration of clinical trial drugs.
7. Those who have the ability and willingness to participate during the entire clinical trail.

Exclusion Criteria:

1. Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
2. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
3. Those who have the test results written below

   * AST, ALT \> 2 times higher than upper normal level
4. Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.

   * Beer 1 glass(250ml, Alcohol contents 5%) = 10g
   * Soju 1 glass(50ml, Alcohol contents 20%) = 8g
   * Wine 1 glass(125ml, Alcohol contents 12%) = 12g
5. Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
6. Those who received investigational durg by participating in other clinical trial within 6 months before the first administration of investigational drug.
7. Those who have vital sign written below

   * systolic blood pressure ≥140 mmHg or \< 90 mmHg
   * diastolic blood pressure ≥ 90 mmHg or \< 60 mmHg
8. Those who have a drug or alcohol abuse history within 1 year before the first administration of investigational drug.
9. Those who take barbiturate and related (causing induction or inhibition. of metabolism) drug within 30 days before the first administration of investigational drug.
10. Those who received Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of investigational drug.
11. Those who donated whole blood within 2 months or apheresis within 1 month before the first administration of investigational drug.
12. Those who severe acute/chronic medical or mental condition which can increase the safety risk by administration of investigational drug.
13. Those who have history of hypersensitivity to active pharmaceutical ingredient or additives.
14. Those who are pregnant or breastfeeding.
15. Those who can't ingest a high fat diet.
16. Those who are deemed inappropriate to participate in clinical trial by investigators.

Primary outcomes:
measure: AUCt of CKD-501, D759, H053
timeFrame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
measure: Cmax of CKD-501, D759, H053
timeFrame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min Gul Kim, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: