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

Sponsor
LG Chem
Study ID
NCT07333742
Phase
PHASE1
Status
Completed

Conditions

  • Fed Conditions
  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
19 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 29, 2025
Status verified
Dec 2025
Primary completion
Nov 27, 2025
Completion
Nov 27, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence A
    Sequence A: Test drug -\> Reference drug
  • Experimental: Sequence B
    Sequence B: Reference drug -\> Test drug

Primary Outcome Measure

The plasma concentration of gemigliptin, dapagliflozin, and metformin [ Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration ]

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