Clinical Study to Evaluate Pharmacokinetic Profiles and Safety of CKD-387 Under Fasting Condition

NCT ID: NCT05673369

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-02-27

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fasting condition.

Detailed Description

Evaluation of Pharmacokinetic profiles and Safety of CKD-387.

Conditions

Endocrine, Nutritional and Metabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Period 1: Reference drug Period 2: Test drug

Group Type: EXPERIMENTAL

CKD-387

Intervention Type: DRUG

1 Tablet

D484

Intervention Type: DRUG

1 Tablet

Group 2

Period 1: Test drug Period 2: Reference drug

Group Type: EXPERIMENTAL

CKD-387

Intervention Type: DRUG

1 Tablet

D484

Intervention Type: DRUG

1 Tablet

Interventions

CKD-387

1 Tablet

Intervention Type: DRUG

D484

1 Tablet

Intervention Type: DRUG

Other Intervention Names

Test; Referernce

Eligibility Criteria

Inclusion Criteria

1. Healthy adults volunteers aged between 19 and 54 years old at the time of screening

2. 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

3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years

4. 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

5. Individuals who signed an informed consent form approved by the IRB of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content

6. 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

7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria

1. 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

2. 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

3. Individuals with the following laboratory test results at screening:

• ALT or AST > 2x the upper limit of the normal range

4. 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)

5. Individuals who smoked more than 20 cigarettes per day within 6 months or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs

6. Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs

7. Following vital signs results at screening

• Sitting systolic blood pressure ≥ 150 mmHg or < 90 mmHg and/or sitting diastolic blood pressure ≥100 mmHg or <50 mmHg

8. Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening

9. 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 administration of investigational drugs

10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugs

11. Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugs

12. 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

13. Individuals with hypersensitivity to investigational products or the investigational products ingredients

14. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)

15. Acute conditions that can affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsis

16. Patients with acute or chronic metabolic acidosis including type 1 diabetes mellitus, lactic acidosis, or diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis

17. Diabetic precoma

18. Patients undergoing intravenous administration of radioactive iodine contrast material (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast medium, etc.)

19. Patients with congestive heart failure or heart failure who require drug treatment (NYHA class IV)

20. Patients with severe infection or severe traumatic systemic disorder

21. Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency

22. Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption

23. Women who are pregnant or may be pregnant

24. Individuals who were deemed to be inappropriate to participate in the study by the investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tae Gon Hong

Role: PRINCIPAL_INVESTIGATOR

Bumin hospital (Seoul)

Locations

Bumin Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A84_10BE2224

Identifier Type: -

Identifier Source: org_study_id