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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1037 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.
This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental |
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| Treatment Sequence BA | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state) | Drug | Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Canagliflozin plasma concentrations | Up to 72 hours | |
| Metformin plasma concentrations | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-14 day washout period between treatment periods (total time is approximately 22 days). | Up to approximately 22 days |
| Clinical Laboratory Tests |
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Inclusion Criteria: - Body mass index (BMI) between 18 and 30 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria: - History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC L.LC. Clinical Trial | Janssen Research & Development, LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25546166 | Derived | Murphy J, Wang SS, Stieltjes H, Wajs E, Devineni D. Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants. Int J Clin Pharmacol Ther. 2015 Mar;53(3):256-64. doi: 10.5414/CP202233. |
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| B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state) | Drug | Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2. |
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Clinically relevant changes from baseline occurring in laboratory safety parameters |
| Up to approximately 22 days |
| Vital Signs | Changes from baseline in blood pressure and pulse | Up to approximately 22 days |