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Not yet recruiting NCT07396844

The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers

Phase I Interventional Healthy Fasting Fed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg.
Who it may be relevant to
Registry conditions: Healthy, Fasting, Fed. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Single Dose, Randomized, Open-label, Two-way Crossover Food-effect Bioavailbility Study of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg Sustained Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers

Overview

This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.

Interventions

  • Drug Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
    All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.

Primary outcome measures

  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [Time frame: 17 times up to 72 hours after IP administration]
  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [Time frame: 17 times up to 72 hours after IP administration]
  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [Time frame: 17 times up to 72 hours after IP administration]
Secondary outcome measures (2)
  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [Time frame: 17 times up to 72 hours after IP administration]
  • The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [Time frame: 17 times up to 72 hours after IP administration]

Eligibility criteria

Inclusion criteria

  • Healthy Thai male and female subjects between the ages of 18 to 55 years.
  • Body mass index between 18.5 to 30.0 kg/m2.
  • Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
  • Non-pregnant woman and not currently breast feeding.
  • Female subjects abstain from either hormonal method of contraception or hormone replacement therapy.
  • Male subjects who are willing or able to use effective contraceptive.
  • Have voluntarily given written informed consent by the subject prior to participating in this study.

Exclusion criteria

  • History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
  • History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness.
  • History of evidence of diabetic ketoacidosis.
  • History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
  • Have a eGFR (CKD-EPI) < 60 mL/min/1.73 m2.
  • History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening.
  • Participated in other clinical trial within 90 days prior to check-in.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Siriraj Hospital — Nakhon Pathom

Identifiers

NCT: NCT07396844 · LG-GMCL002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗