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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1015 | |||
| 2010-023251-28 |
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The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.
This is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin, 50 mg | Drug | Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of canagliflozin | For up to 12 days (4 days during treatment periods 1, 2, and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3) | |
| Clinical laboratory tests | Up to approximately 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27136908 | Derived | Devineni D, Manitpisitkul P, Murphy J, Stieltjes H, Ariyawansa J, Di Prospero NA, Rothenberg P. Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):279-86. doi: 10.1002/cpdd.151. Epub 2014 Dec 11. |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Canagliflozin, 300 mg | Drug | Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods. |
|
| Canagliflozin, 100 mg | Drug | Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods. |
|
| Physical examinations | Up to approximately 42 days |
| 12-lead electrocardiograms (ECGs) | Up to approximately 42 days |
| Vital signs | Up to approximately 42 days |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |