NCT07399470

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.

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-01-09
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: South Korea