Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Co-administration of Saxagliptin and Metformin IR · 1 trial · 1 indication
Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
| Arm | Type | Description |
|---|---|---|
| S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed) | EXPERIMENTAL | Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M \[fasted\]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M \[fed\]) followed by S/M under fasting conditions (S/M \[fasted\]) followed by S + M under fed conditions (S + M \[fed\]) |
| S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed) | EXPERIMENTAL | Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed) |
| S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted) | EXPERIMENTAL | Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted) |
| S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted) | EXPERIMENTAL | Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted) |
| Name | Type | Description |
|---|---|---|
| Co-administration of Saxagliptin and Metformin IR, Fasted | DRUG | Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions |
| Saxagliptin/Metformin, Fasting | DRUG | Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions |
| Co-administration of Saxagliptin and Metformin IR, Fed | DRUG | Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions |
| Saxagliptin/Metformin, Fed | DRUG | Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
Inclusion Criteria: * Men and women ages 19 to 45 inclusive * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 32 kg/m2, incl...
Co-administration of Saxagliptin and Metformin IR refers to giving two oral small-molecule drugs together: saxagliptin and immediate-release metformin. It was studied in healthy volunteers for Type 2 Diabetes Mellitus. The combination was evaluated in a Phase 1 bioequivalence study of saxagliptin and Glucophage combination formulations.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of the co-administration of saxagliptin and Metformin IR. The company sponsored the Phase 1 bioequivalence study of saxagliptin and Glucophage combination formulations conducted in the United States.
Co-administration of Saxagliptin and Metformin IR is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study was a controlled, randomized bioequivalence trial with 24 enrolled participants, and it was not double blind.
Co-administration of Saxagliptin and Metformin IR was evaluated in trial NCT00899470, titled Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A). The Phase 1 trial enrolled 24 healthy volunteers aged 19 years and older of all sexes in the United States, and it is completed.