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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1050 | Other Identifier | Janssen Research & Development |
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The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. |
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| Treatment Sequence BA | Experimental | Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin tablets | Drug | Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Canagliflozin plasma concentrations | Up to 72 hours in Treatment Period 1 and Treatment Period 2 | |
| Metformin plasma concentrations | Up to 24 hours in Treatment Period 1 and Treatment Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in clinical laboratory test values | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | |
| Changes in vital signs measurements | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
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Inclusion Criteria:
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.L.C Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Metformin IR tablets | Drug | Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1. |
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| Canagliflozin/metformin IR FDC tablets | Drug | Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2. |
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| Canagliflozin tablets | Drug | Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2. |
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| Metformin IR tablets | Drug | Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2. |
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| Canagliflozin/metformin IR FDC tablets | Drug | Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1. |
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| Changes in electrocardiogram (ECG) parameters | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| Changes in physical examination results | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| The number of patients reporting adverse events | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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