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Study to Evaluate the Safety and Pharmacokinetics of CKD-379

Primary Purpose

Type II Diabetes Mellitus

Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-379
D759+D745+D029+D150
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 Mellitus

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Between 19 aged and 50 aged in healthy adult 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg Exclusion Criteria: Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery Those who are pregnant or breastfeeding Those who are deemed inappropriate to participate in clinical trial by investigators

Sites / Locations

  • Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)

Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)

Outcomes

Primary Outcome Measures

AUCt
Maximum plasma concentration of the drug
Cmax
Area under the concentration-time curve from the time of dosing to the last measurable concentration

Secondary Outcome Measures

Full Information

First Posted
July 10, 2023
Last Updated
July 17, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05952219
Brief Title
Study to Evaluate the Safety and Pharmacokinetics of CKD-379
Official Title
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
October 30, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination
Detailed Description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)
Intervention Type
Drug
Intervention Name(s)
CKD-379
Intervention Description
2 tablet administration under fed condition
Intervention Type
Drug
Intervention Name(s)
D759+D745+D029+D150
Intervention Description
4 tablet co-administration under fed condition
Primary Outcome Measure Information:
Title
AUCt
Description
Maximum plasma concentration of the drug
Time Frame
0~48hours
Title
Cmax
Description
Area under the concentration-time curve from the time of dosing to the last measurable concentration
Time Frame
0~48hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 19 aged and 50 aged in healthy adult 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg Exclusion Criteria: Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery Those who are pregnant or breastfeeding Those who are deemed inappropriate to participate in clinical trial by investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seol Ju Moon, M.D, Ph.D.
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Pharmacokinetics of CKD-379

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