NCT07396844

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
1mo left

Started Jul 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

February 2, 2026

Last Update Submit

April 8, 2026

Conditions

HealthyFastingFed

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.

    17 times up to 72 hours after IP administration

  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.

    17 times up to 72 hours after IP administration

Other Outcomes (1)

  • Assessment - Safety (Adverse events)

    Up to Day 4 (72 hours)

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 : Period 1 (Fasting) - Period 2 (Fed)

Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

Group 2

EXPERIMENTAL

Group 2 : Period 1 (Fed) - Period 2 (Fasting)

Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

Interventions

Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgDRUG

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.

Group 1Group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
  • 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.
  • History of evidence of diabetic ketoacidosis.
  • History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
  • Have a eGFR (CKD-EPI) \< 60 mL/min/1.73 m2.
  • History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening.
  • Participated in other clinical trial within 90 days prior to check-in.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

FastingLecithin Cholesterol Acyltransferase Deficiency

Interventions

dapagliflozinMetformin

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorHypoalphalipoproteinemiasHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Porranee Puranajoti

    International Bio Service Co., Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Younghwan Jang

CONTACT

02-6987-4154younghj@lgchem.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)