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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02039245 | Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination | PHASE1 | COMPLETED | 12 | — | — | Jan 1, 2014 | Mar 1, 2014 | Apr 2, 2014 | 1 | United States |
| NCT02039258 | Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food | PHASE1 | COMPLETED | 24 | — | — | Jan 1, 2014 | Mar 1, 2014 | Jul 14, 2014 | 1 | United States |
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
| Arm | Type | Description |
|---|---|---|
| Canagliflozin/Metformin XR | EXPERIMENTAL | Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg |
| Sequence AB | EXPERIMENTAL | A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fasted conditions (treatment A) followed by the same single dose under fed conditions (treatment B). |
| Sequence BA | EXPERIMENTAL | A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fed conditions (treatment B) followed by the same single dose under fasted conditions (treatment A). |
| Name | Type | Description |
|---|---|---|
| CANA/MET XR FDC | DRUG | Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth) |
Inclusion Criteria: * Must sign an informed consent document indicating they understand the purpose of the study and procedures * Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive * Must have a body weight of not less than 50 kg * Must have a blood pressure between 90 and 140 ...