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A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal

NCT07333742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-12

No results posted yet for this study

Summary

Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers

Conditions

  • Fed Conditions
  • Healthy Volunteer

Interventions

DRUG

Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

All participants take 1 tablet of either test drug or reference drug after meal.

DRUG

Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

All participants take 1 tablet of either test drug or reference drug after meal.

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D., Professor · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2025-11-27
Completion
2025-11-27

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07333742 on ClinicalTrials.gov