Fasting Conditions, Healthy Volunteers
Conditions
Keywords
Fasting conditions, Healthy Volunteers, Bioequivalence Study
Brief summary
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
Interventions
DRUGTest drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.
DRUGReference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Up to 72 hours | 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. | Up to 72 hours | Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Up to 72 hours | Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeol Ju Moon, M.D., Professor
Jeonbuk National University Hospital
Outcome results
None listed