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Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-370
D745
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 - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adults aged 19 to 55 years
  2. Females who are not pregnant or breastfeeding or who have 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, digestive, urinary, 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) > 1.5 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. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
  4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
  5. Participated in a clinical trial within 90 days prior to first IP dosing
  6. Not eligible to participate for the study at the discretion of Investigator
  7. Other exclusive inclusion criteria, as defined in the protocol

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Period 1: D745 Period 2: CKD-370

Period 1: CKD-370 Period 2: D745

Outcomes

Primary Outcome Measures

AUClast of Empagliflozin
Area under the plasma concentration-time curve to last concentration of Empagliflozin
Cmax of Empagliflozin
Maximum plasma concentration of Empagliflozin

Secondary Outcome Measures

AUCinf of Empagliflozin
Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin
Tmax of Empagliflozin
Time to maximum plasma concentration of Empagliflozin
T1/2 of Empagliflozin
Half-life of Empagliflozin
CL/F of Empagliflozin
Apparent clearance of Empagliflozin
Vd/F of Empagliflozin
Apparent volume of distribution of Empagliflozin

Full Information

First Posted
February 20, 2019
Last Updated
March 10, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03849495
Brief Title
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults
Official Title
A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-370 With D745 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
March 17, 2019 (Anticipated)
Study Completion Date
March 21, 2019 (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 randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers

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
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Period 1: D745 Period 2: CKD-370
Arm Title
Group B
Arm Type
Experimental
Arm Description
Period 1: CKD-370 Period 2: D745
Intervention Type
Drug
Intervention Name(s)
CKD-370
Intervention Description
Test drug
Intervention Type
Drug
Intervention Name(s)
D745
Intervention Description
Reference drug
Primary Outcome Measure Information:
Title
AUClast of Empagliflozin
Description
Area under the plasma concentration-time curve to last concentration of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Cmax of Empagliflozin
Description
Maximum plasma concentration of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Secondary Outcome Measure Information:
Title
AUCinf of Empagliflozin
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Tmax of Empagliflozin
Description
Time to maximum plasma concentration of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Title
T1/2 of Empagliflozin
Description
Half-life of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Title
CL/F of Empagliflozin
Description
Apparent clearance of Empagliflozin
Time Frame
0 hour ~ 48 hour after drug administration
Title
Vd/F of Empagliflozin
Description
Apparent volume of distribution of Empagliflozin
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
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 19 to 55 years Females who are not pregnant or breastfeeding or who have 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, digestive, urinary, 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) > 1.5 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 Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge. Participated in a clinical trial within 90 days prior to first IP dosing Not eligible to participate for the study at the discretion of Investigator Other exclusive inclusion criteria, as defined in the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Sang Yu, Ph.D. M.D.
Phone
+82-2-2072-1920
First Name & Middle Initial & Last Name or Official Title & Degree
Deok Yong Yoon
Phone
+82-2-2072-1930
Email
dyyoon18@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Sang Yu, Ph.D. M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung Sang Yu, Ph.D. M.D.
Phone
+82-2-2072-1920

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

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