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

March 4, 2019 updated by: Chong Kun Dang Pharmaceutical

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kyung-Sang Yu, M.D.,Ph.D
  • Phone Number: +82-2-2072-1920

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  2. Clinical laboratory test values are outside the accepted normal range at Screening
  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 1st 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group 1
  • Period 1: D387 (reference drug)
  • Period 2: CKD-387 (test drug)
Drug: CKD-375
Test drug
Drug: D387
Reference drug
EXPERIMENTAL: Group 2
  • Period 1: CKD-387 (test drug)
  • Period 2: D387 (reference drug)
Drug: CKD-375
Test drug
Drug: D387
Reference drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration of Empagliflozin
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Empagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration of Metformin-time curve from time zero to infinity
Time Frame: 0 hour ~ 48 hour after drug administration
AUCinf of Metformin
0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Time Frame: 0 hour ~ 48 hour after drug administration
Tmax of Metformin
0 hour ~ 48 hour after drug administration
Half-life of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
t1/2 of Metformin
0 hour ~ 48 hour after drug administration
Apparent clearance of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
CL/F of Metformin
0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Vd/F of Metformin
0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity
Time Frame: 0 hour ~ 48 hour after drug administration
AUCinf of Empagliflozin
0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration
Time Frame: 0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin
0 hour ~ 48 hour after drug administration
Half-life of Empagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin
0 hour ~ 48 hour after drug administration
Apparent clearance of Empagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin
0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Empagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin
0 hour ~ 48 hour after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 192BE18036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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