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Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Sequence A: Test drug -> Reference drug |
|
| Sequence B | Experimental | Sequence B: Reference drug -> Test drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg | Drug | All participants take 1 tablet of either test drug or reference drug after meal. |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of gemigliptin, dapagliflozin, and metformin | Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| The plasma concentration of gemigliptin, dapagliflozin, and metformin | Primary Paramenters: Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Secondary Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin | Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from 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 18 (post study visit) |
| Assessment - Safety (Physical examination) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D., Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg | Drug | All participants take 1 tablet of either test drug or reference drug after meal. |
|
Secondary Parameters: Lag Time(Tlag) of gemigliptin, dapagliflozin, and metformin |
| - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Secondary Parameters: Area Under the Curve to Infinity(AUCinf) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Secondary Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Secondary Parameters: Apparent Clearance(CL/F) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Secondary Parameters: Apparent Volume of Distribution(Vz/F) of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration |
Any finding in general condition, nutritional status and other category by medical interview |
| 3 times until 72 hours from IP administration |
| Assessment - Safety (Vital sign) | Systolic Blood Pressure(mmHg), Diastolic Blood Pressure(mmHg), Pulse Rate(beats/min), Temperature(℃) | 7 times until 72 hours from IP administration |
| Assessment - Safety (12-lead ECG results) | Ventricular rate(beats/min), PR interval(msec), QRS(msec), QT(msec), QTcB(msec) | 4 times until post-study visit |
| Assessment - Safety (Clinical laboratory test results) | Hematology, Blood Chemistry, Urinalysis | 4 times until post-study visit |
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| C534891 | LC15-0444 |
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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