Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05266404 | Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components | PHASE1 | COMPLETED | 46 | — | — | Mar 21, 2022 | May 31, 2022 | Jul 5, 2022 | 1 | Germany |
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...