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OpenTrials
Completed

NCT Number: NCT07333742

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

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

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Key information

Conditions

Fed Conditions Healthy Volunteer

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Subjects with clinically significant abnormal findings during tests (or examinations)
  • Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs
  • Subjects judged ineligible by the investigator

Treatment and study plan

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

Drug

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

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

Drug

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

Primary outcomes

  1. The plasma 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

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

  2. The plasma 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

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

Secondary outcomes

  1. The plasma 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

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

  2. The plasma 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

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

  3. The plasma 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

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

  4. The plasma 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

    Secondary Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin

  5. The plasma 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

    Secondary Parameters: Apparent Clearance(CL/F) of gemigliptin, dapagliflozin, and metformin

  6. The plasma 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

    Secondary Parameters: Apparent Volume of Distribution(Vz/F) of gemigliptin, dapagliflozin, and metformin

Other outcomes

  1. Assessment - Safety (Adverse events)

    Time frame: up to day 18 (post study visit)

    A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event.

  2. Assessment - Safety (Physical examination)

    Time frame: 3 times until 72 hours from IP administration

    Any finding in general condition, nutritional status and other category by medical interview

  3. Assessment - Safety (Vital sign)

    Time frame: 7 times until 72 hours from IP administration

    Systolic Blood Pressure(mmHg), Diastolic Blood Pressure(mmHg), Pulse Rate(beats/min), Temperature(℃)

  4. Assessment - Safety (12-lead ECG results)

    Time frame: 4 times until post-study visit

    Ventricular rate(beats/min), PR interval(msec), QRS(msec), QT(msec), QTcB(msec)

  5. Assessment - Safety (Clinical laboratory test results)

    Time frame: 4 times until post-study visit

    Hematology, Blood Chemistry, Urinalysis

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Randomized, Open Label, Single Oral Dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg and Coadministration of Gemigliptin 50 mg and Dapagliflozin/Metformin 10/1000 mg in Healthy Adults in Fed Condition

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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