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The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
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 Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  1. Healthy adults aged 19 to 55 years
  2. Females must be menopause or surgical infertility
  3. Signed informed consent form
  4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

  1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder

  2. Clinical laboratory test values are outside the accepted normal range at Screening

    • aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
    • Total Bilirubin > 1.5 times the upper limit of the normal range
    • creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
    • estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
    • Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
    • systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg
  3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
  4. Participated in a clinical trial within 90 days prior to 1st IP dosing
  5. Not eligible to participate for the study at the discretion of Investigator
  6. Other exclusive inclusion criteria, as defined in the protocol

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Period 1: D484 Period 2: CKD-387

Period 1: CKD-387 Period 2: D484

Outcomes

Primary Outcome Measures

Maximum plasma concentration of Metformin
Cmax of Metformin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
AUClast of Metformin

Secondary Outcome Measures

Area under the plasma concentration of Metformin-time curve from time zero to infinity
AUCinf of Metformin
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Tmax of Metformin
Half-life of Metformin
t1/2 of Metformin
Apparent clearance of Metformin
CL/F of Metformin
Apparent volume of distribution of Metformin
Vd/F of Metformin

Full Information

First Posted
November 7, 2018
Last Updated
February 19, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03738449
Brief Title
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition
Official Title
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 Under Fed Condition in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 24, 2019 (Actual)

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
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: D484 Period 2: CKD-387
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: CKD-387 Period 2: D484
Intervention Type
Drug
Intervention Name(s)
CKD-387
Intervention Description
Test drug
Intervention Type
Drug
Intervention Name(s)
D484
Intervention Description
reference drug
Primary Outcome Measure Information:
Title
Maximum plasma concentration of Metformin
Description
Cmax of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
Description
AUClast of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Secondary Outcome Measure Information:
Title
Area under the plasma concentration of Metformin-time curve from time zero to infinity
Description
AUCinf of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Description
Tmax of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Half-life of Metformin
Description
t1/2 of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Apparent clearance of Metformin
Description
CL/F of Metformin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Apparent volume of distribution of Metformin
Description
Vd/F of Metformin
Time Frame
0 hour ~ 48 hour after drug administration

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 adults aged 19 to 55 years Females must be menopause or surgical infertility Signed informed consent form Other inclusion criteria, as defined in the protocol Exclusion Criteria: History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder Clinical laboratory test values are outside the accepted normal range at Screening aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range Total Bilirubin > 1.5 times the upper limit of the normal range creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease) Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization Participated in a clinical trial within 90 days prior to 1st IP dosing Not eligible to participate for the study at the discretion of Investigator Other exclusive inclusion criteria, as defined in the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, Ph.D. M.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

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