NCT07333742

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

A Randomized, Open Label, Single Oral Dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg and Coadministration of Gemigliptin 50 mg and Dapagliflozin/Metformin 10/1000 mg in Healthy Adults in Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (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 fed conditions in healthy volunteers

Conditions

• Fed Conditions
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg	All participants take 1 tablet of either test drug or reference drug after meal.
DRUG	Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg	All participants take 1 tablet of either test drug or reference drug after meal.

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-11-27
• Completion: 2025-11-27
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: South Korea