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

LG Chem

Status and phase: Completed; Phase 1

Conditions: Fed Conditions; Healthy Volunteer

Treatments: Drug: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07333742

LG-GMCL001

Details and patient eligibility

About

Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers

Enrollment: 50 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 19-50 years in healthy volunteers
2. 18.0 kg/m^2 ≤ BMI ≤ 29.9 kg/m^2, 50kg ≤weight ≤ 90kg
3. 60≤ FPG≤125 mg/dL
4. Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial.

Exclusion criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system.
2. Subjects with clinically significant abnormal findings during tests (or examinations)
3. Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs
4. Subjects judged ineligible by the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Sequence A

Experimental group

Description:

Sequence A: Test drug -\> Reference drug

Treatment:

Drug: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

Drug: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg

Sequence B

Experimental group

Description:

Sequence B: Reference drug -\> Test drug

Treatment:

Drug: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

Drug: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg