Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CANA/MET · 2 trials · 1 indication
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 ...
CANA/MET is an investigational fixed dose combination product developed by Johnson & Johnson (ticker JNJ). It combines canagliflozin and metformin into single tablet formulations, including extended release versions, and has been studied in Phase 1 clinical trials in healthy volunteers. The specific patient populations it is intended to treat have not been publicly disclosed.
CANA/MET is developed by Johnson & Johnson, which trades under the ticker JNJ. The product is a fixed dose combination of canagliflozin and metformin, and the company has conducted Phase 1 pharmacokinetic studies of several dose strengths, including 50 mg/500 mg, 150 mg/500 mg, 50 mg/1000 mg, and 150 mg/1,000 mg formulations.
CANA/MET is in Phase 1 clinical development. Two Phase 1 trials have been completed, both evaluating pharmacokinetics in healthy volunteers. The drug is investigational and has not been approved by the FDA. No active trials are currently listed for this fixed dose combination.
CANA/MET has been studied in two completed Phase 1 trials. NCT02039258 evaluated the pharmacokinetics of a fixed dose combination of canagliflozin and metformin when coadministered with food in 24 healthy volunteers. NCT02039245 evaluated multiple dose pharmacokinetics of the canagliflozin/metformin 150/1,000 mg fixed dose combination in 12 healthy volunteers. Both trials were conducted in the United States.