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 Chem50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Fed Conditions Healthy Volunteer

Interventions

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

All participants take 1 tablet of either test drug or reference drug after meal.

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

All participants take 1 tablet of either test drug or reference drug after meal.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The plasma concentration of gemigliptin, dapagliflozin, and metformin

Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin

Time frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

The plasma concentration of gemigliptin, dapagliflozin, and metformin

Primary Paramenters: Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, and metformin

Time frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

Secondary Outcomes

The plasma concentration of gemigliptin, dapagliflozin and metformin

Secondary Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin

Time frame: Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from IP administration

The plasma concentration of gemigliptin, dapagliflozin and metformin

Secondary Parameters: Lag Time(Tlag) of gemigliptin, dapagliflozin, and metformin

Time frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

The plasma concentration of gemigliptin, dapagliflozin and metformin

Secondary Parameters: Area Under the Curve to Infinity(AUCinf) of gemigliptin, dapagliflozin, and metformin

Time frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

The plasma concentration of gemigliptin, dapagliflozin and metformin

Data from ClinicalTrials.gov

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