Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 : Period 1 (Fasting) - Period 2 (Fed) |
|
| Group 2 | Experimental | Group 2 : Period 1 (Fed) - Period 2 (Fasting) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. | Primary PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin | 17 times up to 72 hours after IP administration |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. | Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin | 17 times up to 72 hours after IP administration |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. | Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin | 17 times up to 72 hours after IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. | Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin | 17 times up to 72 hours after IP administration |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment - Safety (Adverse events) | A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event. | Up to Day 4 (72 hours) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Younghwan Jang | Contact | 02-6987-4154 | younghj@lgchem.com |
| Name | Affiliation | Role |
|---|---|---|
| Porranee Puranajoti | International Bio Service Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Nakhon Pathom | 73170 | Thailand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Secondary PK Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin |
| 17 times up to 72 hours after IP administration |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided