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

Primary Purpose

Endocrine, Nutritional and Metabolic Diseases

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-387
D484
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endocrine, Nutritional and Metabolic Diseases

Eligibility Criteria

19 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults volunteers aged between 19 and 54 years old 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 Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content 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 or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs 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 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 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 administration of investigational drugs Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugs Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugs 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 Patients with nephropathy (eGFR<60 ml/min/1.73 m2) Acute conditions that can affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsis 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 Diabetic precoma Patients undergoing intravenous administration of radioactive iodine contrast material (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast medium, etc.) Patients with congestive heart failure or heart failure who require drug treatment (NYHA class IV) Patients with severe infection or severe traumatic systemic disorder Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption Women who are pregnant or may be pregnant Individuals who were deemed to be inappropriate to participate in the study by the investigator

Sites / Locations

  • Bumin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Period 1: Reference drug Period 2: Test drug

Period 1: Test drug Period 2: Reference drug

Outcomes

Primary Outcome Measures

AUCt of CKD-387, D484
Area under the CKD-387, D484 concentration in blood-time curve from 0 to t
Cmax of CKD-387, D484
The maximum CKD-387, D484 concentration in blood sampling time t

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
January 4, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05673369
Brief Title
Clinical Study to Evaluate Pharmacokinetic Profiles and Safety of CKD-387 Under Fasting Condition
Official Title
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fasting Condition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
February 11, 2023 (Anticipated)
Study Completion Date
February 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine, Nutritional and Metabolic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: Reference drug Period 2: Test drug
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: Test drug Period 2: Reference drug
Intervention Type
Drug
Intervention Name(s)
CKD-387
Other Intervention Name(s)
Test
Intervention Description
1 Tablet
Intervention Type
Drug
Intervention Name(s)
D484
Other Intervention Name(s)
Referernce
Intervention Description
1 Tablet
Primary Outcome Measure Information:
Title
AUCt of CKD-387, D484
Description
Area under the CKD-387, D484 concentration in blood-time curve from 0 to t
Time Frame
(Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hour
Title
Cmax of CKD-387, D484
Description
The maximum CKD-387, D484 concentration in blood sampling time t
Time Frame
(Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults volunteers aged between 19 and 54 years old 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 Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content 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 or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs 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 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 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 administration of investigational drugs Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugs Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugs 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 Patients with nephropathy (eGFR<60 ml/min/1.73 m2) Acute conditions that can affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsis 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 Diabetic precoma Patients undergoing intravenous administration of radioactive iodine contrast material (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast medium, etc.) Patients with congestive heart failure or heart failure who require drug treatment (NYHA class IV) Patients with severe infection or severe traumatic systemic disorder Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption Women who are pregnant or may be pregnant Individuals who were deemed to be inappropriate to participate in the study by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Gon Hong
Phone
+82-2-2620-0251
Email
tghong@bumin.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Gon Hong
Organizational Affiliation
Bumin hospital (Seoul)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bumin Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Gon Hong
Phone
+82-2-2620-0251
Email
tghong@bumin.co.kr

12. IPD Sharing Statement

Learn more about this trial

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

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