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A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.

NCT07399470 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-10

No results posted yet for this study

Summary

Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers

Conditions

  • Healthy Volunteers
  • Fasting Conditions

Interventions

DRUG

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

All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.

DRUG

Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg

All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Seol Ju Moon, M.D., Professor · Jeonbuk 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
2026-01-09
Primary Completion
2026-02-28
Completion
2026-02-28

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 NCT07399470 on ClinicalTrials.gov