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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02065752 | A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components | PHASE1 | COMPLETED | 2 | — | — | Feb 1, 2014 | Apr 1, 2014 | Jun 17, 2014 | 1 | United States |
| NCT02073227 | A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components | PHASE1 | COMPLETED | 52 | — | — | Feb 1, 2014 | Jun 1, 2014 | Sep 9, 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 |
|---|---|---|
| Treatment A | EXPERIMENTAL | Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions. |
| Treatment B | EXPERIMENTAL | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions. |
| Treatment C | EXPERIMENTAL | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions. |
| Name | Type | Description |
|---|---|---|
| Canagliflozin, 100 mg | DRUG | Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth). |
| Metformin XR, 500 mg | DRUG | Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth). |
| CANA/MET XR FDC, Formulation 1, 50 mg/500 mg | DRUG | Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally. |
| CANA/MET XR FDC, Formulation 2, 50 mg/500 mg | DRUG | Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally. |
| Canagliflozin, 300 mg | DRUG | Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth). |
| CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg | DRUG | Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally. |
| CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg | DRUG | Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally. |
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 ...