Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

September 9, 2020 updated by: LG Chem

Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

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

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component

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.
44

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.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adults who are 19 years ~ 50 years when they are screened
  2. weight: 55.0 kg ~ 90.0 kg and BMI: 18.0 kg/m2 ~ 30.0 kg/m2
  3. Volunteers who understand the procedures of clinical trial and signed informed consent form
  4. Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
  5. Women of chlidbearing potential have negative results in pregnancy test

Exclusion Criteria:

  1. Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
  2. Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
  3. GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
  4. Chronic urine track infection
  5. Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
  6. galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

  7. These resluts are appeared when screening

    • ALT, AST >= 1.5 Upper limit of normal range
    • HbsAg, anti-HCV, HIV Ag&Ab positive
    • MDRD equation: eGFR< 60 mL/min/1.73m2
    • QTcB> 450 ms
    • Fasting serum glucose < 70mg/dL or >110mg/dL
    • HbA1c>6.5%
  8. SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: Arm I
Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Drug: Zemiglo 50mg and Forxiga 10mg
Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
Other Names:
  • zemiglo and Forxiga
Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD
Other Names:
  • zemiglo and Forxiga
Experimental: Arm II
Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
Drug: Zemiglo 50mg and Forxiga 10mg
Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
Other Names:
  • zemiglo and Forxiga
Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD
Other Names:
  • zemiglo and Forxiga

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
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Pre-dose (Day1 0 hour)
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour)
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 0.25hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 0.25hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 0.5hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 0.5hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 0.75hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 0.75hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 1hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 1hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 1.5hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 1.5hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 2hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 2hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 3hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 3hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 4hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 4hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 6hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 6hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 8hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 8hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 10hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 10hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 12hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 12hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 24hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 24hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 36hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 36hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 48hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 48hour
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 72hour
each phase 17 times blood sampling, total 34 times blood sampling
Day 1 72hour

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
Gemigliptin and dapagliflozin AUCinf
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin Tmax
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin t1/2
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin CL/F
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin V/F
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUClast
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) Cmax
Time Frame: Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUCinf
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) t1/2
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) metabolic ratio
Time Frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
each phase 17 times blood sampling, total 34 times blood sampling
Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour

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

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.
October 1, 2020

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.
March 1, 2021

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.
July 1, 2021

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).
July 29, 2020

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.
September 8, 2020

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.
September 10, 2020

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.
September 11, 2020

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.
September 9, 2020

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.
September 1, 2020

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-GLCL002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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