Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07399470
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea