Phase 1Completed
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
- Sponsor
- LG Chem (Industry)
- Enrolment
- 58 enrolled
- Conditions
- Healthy Volunteers; Fasting Conditions
- Interventions
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Ages
- adults
- Registry
- NCT07399470
Full record on ClinicalTrials.gov
From the registry
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
Primary outcomes
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
History
Last registry update
Registered
Primary completion
Started