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The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CKD-375

D387

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:

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, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
Clinical laboratory test values are outside the accepted normal range at Screening
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 1st IP dosing
Not eligible to participate for the study at the discretion of Investigator
Other exclusive inclusion criteria, as defined in the protocol

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Period 1: D387 (reference drug) Period 2: CKD-387 (test drug)

Period 1: CKD-387 (test drug) Period 2: D387 (reference drug)

Outcomes

Primary Outcome Measures

Maximum plasma concentration of Empagliflozin

Cmax of Empagliflozin

Maximum plasma concentration of Metformin

Cmax of Metformin

Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration

AUClast of Empagliflozin

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 Empagliflozin-time curve from time zero to infinity

AUCinf of Empagliflozin

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 Empagliflozin following drug administration

Tmax of Empagliflozin

Time to reach maximum (peak) plasma concentration of Metformin following drug administration

Tmax of Metformin

Half-life of Empagliflozin

t1/2 of Empagliflozin

Half-life of Metformin

t1/2 of Metformin

Apparent clearance of Empagliflozin

CL/F of Empagliflozin

Apparent clearance of Metformin

CL/F of Metformin

Apparent volume of distribution of Empagliflozin

Vd/F of Empagliflozin

Apparent volume of distribution of Metformin

Vd/F of Metformin

Full Information

NCT ID

NCT03848637

First Posted

February 19, 2019

Last Updated

March 4, 2019

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT03848637

Brief Title

The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

Official Title

A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 14, 2019 (Anticipated)

Primary Completion Date

April 24, 2019 (Anticipated)

Study Completion Date

May 1, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 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

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Period 1: D387 (reference drug) Period 2: CKD-387 (test drug)

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Period 1: CKD-387 (test drug) Period 2: D387 (reference drug)

Intervention Type

Drug

Intervention Name(s)

CKD-375

Intervention Description

Test drug

Intervention Type

Drug

Intervention Name(s)

D387

Intervention Description

Reference drug

Primary Outcome Measure Information:

Title

Maximum plasma concentration of Empagliflozin

Description

Cmax of Empagliflozin

Time Frame

Time Frame: 0 hour ~ 48 hour after drug administration

Title

Maximum plasma concentration of Metformin

Description

Cmax of Metformin

Time Frame

Time Frame: 0 hour ~ 48 hour after drug administration

Title

Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration

Description

AUClast of Empagliflozin

Time Frame

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

Time Frame: 0 hour ~ 48 hour after drug administration

Secondary Outcome Measure Information:

Title

Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity

Description

AUCinf of Empagliflozin

Time Frame