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.

Conditions

• Fasting Conditions
• Healthy Volunteers

Eligibility Criteria

Sex

ALL

Age

19 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg — DRUG
  All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.
• Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg — DRUG
  All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.

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

First listed

Feb 10, 2026

Start date

Jan 9, 2026

Status verified

Jul 2026

Primary completion

Feb 6, 2026

Completion

Feb 6, 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

• Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
  Recruiting · National Institute of Mental Health (NIMH) · Bethesda, Maryland
• Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
  Enrolling By Invitation · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
• Cytapheresis of Volunteer Donors
  Recruiting · National Institute on Aging (NIA) · Baltimore, Maryland
• Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland