NCT07396844
Not yet recruiting
Phase 1
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
LG Chem1 site in 1 country28 target enrollmentStarted: July 1, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- LG Chem
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m
- •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 m
- •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.
Arms & Interventions
Group 1
Experimental
Group 1 : Period 1 (Fasting) - Period 2 (Fed)
Intervention: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Group 2
Experimental
Group 2 : Period 1 (Fed) - Period 2 (Fasting)
Intervention: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Outcomes
Primary Outcomes
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time Frame: 17 times up to 72 hours after IP administration
Primary PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
Secondary Outcomes
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.(17 times up to 72 hours after IP administration)
Investigators
Study Sites (1)
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