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A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378

Primary Purpose

Type II Diabetes

Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-378, QD, PO Drug: D745, D150, QD, PO
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring CKD-378

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 50kg(woman) Body mass index (BMI) of 18.5 to 27.0kg/m2 If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized. Those who agree to contraception from the first IP dosing day till 28 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who have significant disease or medical history of urinary infection. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. Those who have tested inappropriate in screening test 28 days prior to IP administration. AST, ALT > 1.5 times higher than upper normal level eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2 "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg. Those who has a drug abuse history within one year or positivie reaction on urine drug screening test. Woman who are pregnant or breastfeeding Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who have used following drugs that can interfere with the study or have impact on safety of the subject. ETC, herbal medicinal preparations within 14 days before the first dosing date OTC, vitamins, health supplement within 7 days before the first dosing date Depot injection or implantation within 30 days before the first dosing date Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days Those who have received blood transfusion in 30 days Those who are deemed insufficient to participate in clinical study by investigators

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Period 1: D745, D150 - A single oral dose of 2 tablets under food intake condition Period 2: CKD-378 - A single oral dose of 1 tablet under food intake condition

Period 1: CKD-378 - A single oral dose of 1 tablet under food intake condition Period 2: D745, D150 - A single oral dose of 2 tablets under food intake condition

Outcomes

Primary Outcome Measures

1. AUCt of CKD-378: Area under the concentration-time curve time zero to time
2. Cmax of CKD-378: Maximum plasma concentration of the drug

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05741437
Brief Title
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378
Official Title
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 10, 2023 (Anticipated)
Primary Completion Date
May 19, 2023 (Anticipated)
Study Completion Date
May 26, 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
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
Detailed Description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
CKD-378

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: D745, D150 - A single oral dose of 2 tablets under food intake condition Period 2: CKD-378 - A single oral dose of 1 tablet under food intake condition
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-378 - A single oral dose of 1 tablet under food intake condition Period 2: D745, D150 - A single oral dose of 2 tablets under food intake condition
Intervention Type
Drug
Intervention Name(s)
CKD-378, QD, PO Drug: D745, D150, QD, PO
Intervention Description
Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO
Primary Outcome Measure Information:
Title
1. AUCt of CKD-378: Area under the concentration-time curve time zero to time
Time Frame
Pre-dose(0 hour) to 48 hours
Title
2. Cmax of CKD-378: Maximum plasma concentration of the drug
Time Frame
Pre-dose(0 hour) to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 50kg(woman) Body mass index (BMI) of 18.5 to 27.0kg/m2 If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized. Those who agree to contraception from the first IP dosing day till 28 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who have significant disease or medical history of urinary infection. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. Those who have tested inappropriate in screening test 28 days prior to IP administration. AST, ALT > 1.5 times higher than upper normal level eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2 "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg. Those who has a drug abuse history within one year or positivie reaction on urine drug screening test. Woman who are pregnant or breastfeeding Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who have used following drugs that can interfere with the study or have impact on safety of the subject. ETC, herbal medicinal preparations within 14 days before the first dosing date OTC, vitamins, health supplement within 7 days before the first dosing date Depot injection or implantation within 30 days before the first dosing date Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days Those who have received blood transfusion in 30 days Those who are deemed insufficient to participate in clinical study by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Soo Park, M.D.
Phone
+82-10-8740-1611
Email
MINSPARK@YUHS.AC
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, M.D.
Phone
+82-10-8740-1611
Email
MINSPARK@YUHS.AC

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378

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