Approval Probability
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Also known as Dapagliflozin
Dapagliflozin/metformin 5 · 2 trials · 2 indications
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
| Arm | Type | Description |
|---|---|---|
| Dapagliflozin 5mg + Metformin 500mg XR | EXPERIMENTAL | co-administration of a single oral dose of a 5mg dapagliflozin (Forxiga® 5mg) tablet and a 500mg metformin XR (Glucophage XR®) tablet |
| Dapagliflozin/metformin XR FDC 5/500 mg | EXPERIMENTAL | single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR subject |
| Dapagliflozin 10mg + Metformin 1000mg XR | EXPERIMENTAL | co-administration of a single oral dose of a 10mg dapagliflozin (Forxiga® 10mg) tablet and two 500mg metformin XR (Glucophage XR®) tablets |
| Dapagliflozin/metformin XR FDC 10/1000 mg | EXPERIMENTAL | ingle FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR |
| Treatment A | EXPERIMENTAL | Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fed |
| Treatment B | ACTIVE_COMPARATOR | Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fed |
| Treatment C | EXPERIMENTAL | Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fasted |
| Treatment D | ACTIVE_COMPARATOR | Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fasted |
| Treatment E | EXPERIMENTAL | Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fed |
| Treatment F | ACTIVE_COMPARATOR | Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fed |
| Treatment G | EXPERIMENTAL | Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fasted |
| Treatment H | ACTIVE_COMPARATOR | Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fasted |
| Name | Type | Description |
|---|---|---|
| Dapagliflozin/metformin XR FDC 5/500 mg | DRUG | In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. |
| Dapagliflozin/metformin XR FDC 10/1000 mg | DRUG | In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. |
| Dapagliflozin 5 mg + Metformin 500 mg XR | DRUG | In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. |
| Dapagliflozin 10 mg + Metformin 1000 mg XR | DRUG | In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. |
| Dapagliflozin/metformin XR 5/500mg | DRUG | Tablets for oral administration, once daily, once per treatment period |
| Dapagliflozin/metformin XR 5/500 mg | DRUG | Tablets for oral administration, once daily, once per treatment period |
| Dapagliflozin/metformin XR 10/1000mg | DRUG | Tablets for oral administration, once daily, once per treatment period |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Healthy Chinese subjects as determined by no clinically significant deviation from normal in medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory evaluations. 3. Male ...
Dapagliflozin is an investigational small molecule being developed for cardiovascular and metabolic conditions, including diabetes mellitus, chronic kidney disease, heart failure with preserved ejection fraction, and type 1 diabetes mellitus. It is also studied in healthy volunteers for bioequivalence assessments. The drug is in Phase 3 clinical development.
Dapagliflozin is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Dapagliflozin is in Phase 3 clinical development. It has completed 20 clinical trials with a total enrollment of 17,379 participants. The trials are randomized, double-blind, and placebo-controlled, indicating a rigorous evaluation process for the drug's efficacy and safety.
Dapagliflozin has completed several clinical trials, including NCT01294436 in Japanese subjects with type 2 diabetes, NCT02279407 for liver fat in diabetic patients, NCT03877237 for heart failure with reduced ejection fraction, and NCT04856007 for bioequivalence in healthy Chinese subjects. All trials are completed.
Dapagliflozin is also known by the brand name Farxiga, which is a medication used to treat type 2 diabetes. In clinical trials, it is being studied for additional indications such as heart failure and chronic kidney disease. The drug is developed by AstraZeneca.