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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.
A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 5 mg dapagliflozin and 850 mg Glucophage in fasted state |
|
| 2 | Experimental | dapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted |
|
| 3 | Experimental | 5 mg dapagliflozin and 850 mg Glucophage in fed state |
|
| 4 | Experimental | dapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin + Glucophage tablet fasted | Drug | Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve over the time (AUC) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t)) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Maximum concentration (Cmax) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum analyte concentration (tmax) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Terminal rate constant (λz) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Johnsson, MD | AstraZeneca Research and Development SE-431 83 Mölndal Sweden | Study Director |
| Saeed Kahn, MBBS | Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR | Principal Investigator |
| Mirjana Kujacic, PHD | AstraZeneca Research and DevelopmentSE-431 83 Mölndal Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26048185 | Result | Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW. Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004. Epub 2015 Jun 3. |
| Label | URL |
|---|---|
| D1691C00007\_CSR\_Synopsis | View source |
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| Dapagliflozin/metformin IR FDC tablet fasted | Drug | single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state |
|
| Dapagliflozin + Glucophage tablet fed | Drug | Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state |
|
| Dapagliflozin/metformin IR FDC tablet fed | Drug | single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state |
|
No statistical analysis will be performed |
| pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Time of last quantifiable analyte concentration (tlast) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Terminal half-life (t1/2) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Observed maximum analyte concentration (Cmax) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t)) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Elimination terminal half-life (t1/2) | No statistical analysis will be performed | pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose |
| Safety profile description in term of Adverse Events | No statistical analysis will be performed | from first dose in treatment period 1 up to 10 days after final dose |
| Safety profile description in term of Blood Pressure | No statistical analysis will be performed | at screening, once daily during the residential period (5 days each) and up to 10 days after final dose |
| Safety profile description in term of Physical Examination | No statistical analysis will be performed | at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose |
| Safety profile description in term of Electrocardiogram ECG | No statistical analysis will be performed | at screening and up to 10 days after final dose |
| Safety profile description in term of Heart Rate | No statistical analysis will be performed | at screening, once daily during the residential period (5 days each) and up to 10 days after final dose |
| Safety profile description in term of Safety Labs | No statistical analysis will be performed | at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose |
| D1691C00007\_Clinical\_Study\_Protocol | View source |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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