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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07396844

Enrollment

Registered

2026-02-09

Start date

2026-06-11

Completion date

2026-06-26

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Fed, Healthy

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.

Interventions

DRUGFixed-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy Thai male and female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.5 to 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. 4. Non-pregnant woman and not currently breast feeding. 5. Female subjects abstain from either hormonal method of contraception or hormone replacement therapy. 6. Male subjects who are willing or able to use effective contraceptive. 7. Have voluntarily given written informed consent by the subject prior to participating in this study.

Exclusion criteria

1. History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin. 2. 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. 3. History of evidence of diabetic ketoacidosis. 4. History of evidence of genital infections, urinary tract infections within 14 days prior to check-in. 5. Have a eGFR (CKD-EPI) \< 60 mL/min/1.73 m2. 6. History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening. 7. Participated in other clinical trial within 90 days prior to check-in.

Design outcomes

Primary

Measure	Time frame	Description
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.	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

Measure	Time frame	Description
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.	17 times up to 72 hours after IP administration	Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORPorranee Puranajoti

International Bio Service Co., Ltd.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026