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.

Sponsor
LG Chem
Study ID
NCT07399470
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Fasting Conditions
  • Healthy Volunteers

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 fasting conditions in healthy volunteers

Key Dates

Start date
Jan 9, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

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

Arms

  • Experimental: Sequence 1
    test drug \> reference drug
  • Experimental: Sequence 2
    reference drug \> test drug

Primary Outcome Measure

The plasma concentration of Gemigliptin, Dapagliflozin and Metformin [ Time Frame: Up to 72 hours ]

Related Studies