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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1039 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of 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 of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. |
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| Treatment Sequence BA | Experimental | The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Canagliflozin tablet | Drug | Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A. |
| Measure | Description | Time Frame |
|---|---|---|
| Canagliflozin plasma concentrations | Up to 72 hours | |
| Metformin plasma concentrations | Up to 72 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 10-15 washout period between treatment periods (total time is approximately 23 days). | Up to approxmately 23 days |
| Changes from baseline in clinical laboratory test results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC L.LC. Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | United States |
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| Treatment A: Metformin IR tablets | Drug | Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A. |
|
| Treatment B: Canagliflozin/metformin fixed dose combination tablets | Drug | Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B. |
|
| Up to approximately 23 days |
| Vital Signs | Blood pressure, pulse, and oral body temperature | Up to approximately 23 days |
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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