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Also known as Dapagliflozin
Dapagliflozin/sitagliptin · 1 trial · 1 indication
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tablet | EXPERIMENTAL | Subjects will receive single dose of dapagliflozin/sitagliptin fixed dose combination (FDC) (test formulation). |
| Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin | ACTIVE_COMPARATOR | Subjects will receive single dose of dapagliflozin 10 mg tablet + sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation). |
| Name | Type | Description |
|---|---|---|
| Dapagliflozin/sitagliptin FDC | DRUG | Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally. |
| Sitagliptin | DRUG | Subjects will receive 100 mg single dose of Sitagliptin orally. |
| Dapagliflozin | DRUG | Subjects will receive 10 mg single dose of Dapagliflozin orally. |
Inclusion Criteria: * Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. * Females must have a negative serum pregnancy test at Screening and negative urine pregnancy test within 24 hours prior to investigational Medicinal product (IMP...
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.