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NOT YET RECRUITING
NCT07396844
PHASE1

The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers

Sponsor: LG Chem

View on ClinicalTrials.gov

Summary

This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.

Official title: A Single Dose, Randomized, Open-label, Two-way Crossover Food-effect Bioavailbility Study of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg Sustained Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-07-01

Completion Date

2026-07-31

Last Updated

2026-02-09

Healthy Volunteers

Yes

Interventions

DRUG

Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.

Locations (1)

Siriraj Hospital

Nakhon Phanom, Thailand