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
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 20 mg, once daily, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together | plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride | for 72 hours after each administered dose | |
| Recorded adverse events | for 72 hours after each administered dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Vicente López | Buenos Aires | 1602 | Argentina |
Not provided
| Label | URL |
|---|---|
| MB102-016 \_CSR \_synosis | View source |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C057619 | glimepiride |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Glimepiride |
| Drug |
Tablets, Oral, 4 mg, once daily, single dose |
|
| Dapagliflozin + Glimepiride | Drug | Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose |
|
| D004700 | Endocrine System Diseases |