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Completed

NCT Number: NCT07399470

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.

Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers

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Key information

Conditions

Healthy Volunteers Fasting Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults between 19 and 50 years of age
  • People with a body weight within a healthy range
  • People who do not have serious medical conditions and have been generally healthy in recent years
  • People whose screening tests (blood tests, urine tests, vital signs, ECG, etc.) show no significant abnormalities
  • Women of childbearing potential must not be pregnant at screening
  • Participants must agree to use reliable contraception or abstain from sexual activity during the study and for a short period after the last dose
  • People who fully understand the study, agree to follow study requirements, and provide written informed consent

Exclusion criteria

  • People with a history of significant diseases, such as heart, liver, kidney, lung, neurological, psychiatric, immune, or cancer-related conditions
  • People with digestive diseases or surgeries that may affect how medicines are absorbed
  • People with abnormal screening laboratory results, especially related to liver or kidney function
  • People who drink large amounts of alcohol, use drugs, or smoke heavily
  • People who have recently taken certain medications, herbal products, or dietary supplements that could interfere with the study
  • People who have recently participated in another clinical trial, donated blood, or received a blood transfusion
  • Pregnant or breastfeeding women
  • People with unstable or serious health conditions that could increase risk or affect study results
  • Anyone who, in the opinion of the study doctor, is not suitable to participate

Treatment and study plan

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

Drug

All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.

Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg

Drug

All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.

Primary outcomes

  1. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

    Time frame: Up to 72 hours

    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: Up to 72 hours

    Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin

Secondary outcomes

  1. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.

    Time frame: Up to 72 hours

    Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin

  2. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

    Time frame: Up to 72 hours

    Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin

  3. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

    Time frame: Up to 72 hours

    Area Under the Curve to Infinity(AUCinf) of Gemigliptin, Dapagliflozin, and Metformin

  4. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

    Time frame: Up to 72 hours

    Half-life(t1/2) of Gemigliptin, Dapagliflozin, and Metformin

  5. The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

    Time frame: Up to 72 hours

    Apparent Clearance(CL/F) of Gemigliptin, Dapagliflozin, and Metformin

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Jul 24, 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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