The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers

September 4, 2026 updated by: LG Chem

A Single Dose, Randomized, Open-label, Two-way Crossover Food-effect Bioavailbility Study of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg Sustained Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers

This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • 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

  • Thailand
      • Nakhon Pathom, Thailand, 73170
        • Siriraj Hospital

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy Thai male and female subjects between the ages of 18 to 55 years.
  2. Body mass index between 18.5 to 30.0 kg/m2.
  3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
  4. Non-pregnant woman and not currently breast feeding.
  5. Female subjects abstain from either hormonal method of contraception or hormone replacement therapy.
  6. Male subjects who are willing or able to use effective contraceptive.
  7. Have voluntarily given written informed consent by the subject prior to participating in this study.

Exclusion Criteria:

  1. History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
  2. History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness.
  3. History of evidence of diabetic ketoacidosis.
  4. History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
  5. Have a eGFR (CKD-EPI) < 60 mL/min/1.73 m2.
  6. History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening.
  7. Participated in other clinical trial within 90 days prior to check-in.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Group 1 : Period 1 (Fasting) - Period 2 (Fed)
Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.
Experimental: Group 2
Group 2 : Period 1 (Fed) - Period 2 (Fasting)
Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Primary PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
17 times up to 72 hours after IP administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin
17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Secondary PK Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin
17 times up to 72 hours after IP administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment - Safety (Adverse events)
Time Frame: Up to Day 4 (72 hours)
A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event.
Up to Day 4 (72 hours)

Collaborators and Investigators

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

Sponsor

LG Chem

Investigators

  • Principal Investigator: Porranee Puranajoti, International Bio Service Co., Ltd.

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)

June 11, 2026

Primary Completion (Actual)

June 26, 2026

Study Completion (Actual)

June 26, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GMCL002

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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