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

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: Not yet recruiting
• Conditions: Healthy; Fasting; Fed
• Intervention / Treatment: Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Younghwan Jang; Phone Number: 02-6987-4154; Email: younghj@lgchem.com

Study Locations

• Thailand
  • Nakhon Pathom, Thailand, 73170
    • Siriraj Hospital
    • Contact: Porranee Puranajoti

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	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.	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.	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.	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.	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)	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

• Sponsor: LG Chem
• Investigators: Principal Investigator: Porranee Puranajoti, International Bio Service Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 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): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hypoalphalipoproteinemias; Hypolipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Lecithin Cholesterol Acyltransferase Deficiency; Fasting; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin; dapagliflozin
• 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