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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754NAP1004 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.
This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + canagliflozin (JNJ-28431754) | Experimental | Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754) | Cmax (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin. | Up to Day 8 |
| The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754) | AUC (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin. | Up to Day 8 |
| The maximum plasma concentration (Cmax) of metformin | Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754). | Up to Day 8 |
| The area under the plasma concentration-time curve (AUC) for metformin | AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754). | Up to Day 8 |
| 24-hour urine glucose excretion | 24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin. | Up to Day 10 |
| 24-hour area under the serum glucose concentration-time curve | 24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to 18 days |
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Inclusion Criteria:
Exclusion Criteria:
- History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neptune City | New Jersey | United States |
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| Label | URL |
|---|---|
| An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754 | View source |
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| Canagliflozin (JNJ-28431754) | Drug | Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8. |
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| Up to Day 8 |
| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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