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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.
Sponsor: LG Chem
Summary
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
Official title: Randomized, Open-label, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of a Triple Fixed-dose Combination Tablet (Gemigliptin/Dapagliflozin/Metformin) 50/10/1000 mg and Co-administered Zemiglo (Gemigliptin) 50 mg and Xigduo XR (Dapagliflozin/Metformin) 10/1000 mg in Healthy Adult Subjects Under Fasting Conditions
Key Details
Gender
All
Age Range
19 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2026-01-09
Completion Date
2026-02-28
Last Updated
2026-02-10
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea