Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

June 11, 2018 updated by: LG Chem

An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers

gemigliptin,SGLT-2i DDI study

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.

Detailed Description

LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin & dapagliflozin and gemigliptin & empagliflozin.

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 (Actual)

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.
48

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 Locations

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 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male adults at age between 19 to 55 at the time of the screening
  2. Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
  3. Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
  4. subjects who is consented in writing to be sure to comply with the requirements of the clinical trial

Exclusion Criteria:

  1. Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
  2. Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
  3. Subject who had infection disease or serious injury within 21 days before the randomization
  4. Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
  5. Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
  6. Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
  7. Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
  8. Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
  9. subject who drinks the average amount per week exceeding 140 g of alcohol
  10. Subject whose daily average smoking amount exceeds 20 pieces per day
  11. Average daily grapefruit juice intake exceeding 2 cups
  12. Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
  13. Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
  14. Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
  15. Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
  16. Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
  17. Subject who have clinically significant abnormalities in other clinical tests
  18. Subject with clinically significant abnormal ECG findings
  19. Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment

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: gemigliptin
gemigliptin single dose
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Names:
  • zemiglo
EXPERIMENTAL: dapagliflozin
dapagliflozin single dose
Drug: Dapagliflozin
forxiga, dapagliflozin 10mg
Other Names:
  • forxiga
EXPERIMENTAL: gemigliptin and dapagliflozin
co-administration of gemigliptin and dapagliflozin
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Names:
  • zemiglo
Drug: Dapagliflozin
forxiga, dapagliflozin 10mg
Other Names:
  • forxiga
EXPERIMENTAL: empagliflozin
empagliflozin single dose
Drug: Empagliflozin
jardiance 25mg, empagliflozin
Other Names:
  • jardiance
EXPERIMENTAL: gemigliptin and empagliflozin
co-administration of gemigliptin and empagliflozin
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Names:
  • zemiglo
Drug: Empagliflozin
jardiance 25mg, empagliflozin
Other Names:
  • jardiance

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
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
AUCτ
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Css,max
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours

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
tss,max of gemigliptin, dapagliflozin, empagliflozin
Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
tss,max
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Css,min
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
AUCτ
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Css,max
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Css,min
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio of gemigliptin
Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours

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.
LG Chem

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: jungryul kim, doctor, Samsung Seoul Medical Center

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 (ACTUAL)

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 5, 2018

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.
August 20, 2018

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.
December 22, 2018

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).
May 24, 2018

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.
June 11, 2018

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.
June 21, 2018

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.
June 21, 2018

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.
June 11, 2018

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.
May 1, 2018

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.
  • LG-DPCL018

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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