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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1044 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.
This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).
The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of the 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 4 tablets of metformin extended release (MET XR), 500 mg each, administered together under fed conditions. |
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| Treatment B | Experimental | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions. |
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| Treatment C | Experimental | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin, 300 mg | Drug | Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth). |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of canagliflozin following administration of a single dose of study drug | Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body. | Predose, (before tablet intake) up to 72 hours after dose |
| Plasma concentration of metformin following administration of a single dose of study drug | Plasma concentrations of metformin are used to evaluate how long metformin stays in the body. | Predose, up to 36 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events as a measure of safety and tolerability | Screening, up to Day 10 of the follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Metformin XR, 500 mg | Drug | Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth). |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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