The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01343290
First received: April 1, 2011
Last updated: September 29, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Canagliflozin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- Concentration of canagliflozin in plasma samples [ Time Frame: For up to 8 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events reported [ Time Frame: Up to approximately 34 days ] [ Designated as safety issue: No ]
- Vital signs measurements [ Time Frame: Up to approximately 34 days ] [ Designated as safety issue: No ]
- Results from clinical chemistries performed [ Time Frame: Up to approximately 34 days ] [ Designated as safety issue: No ]
- Results from 12-lead ECGs performed [ Time Frame: Up to approximately 34 days ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | April 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Canagliflozin Type = 1 unit = mg number = 300 form = tablet route = oral use. Single tablet taken with or without a meal during 2 treatment periods
|
Drug: Canagliflozin
Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods
|
Detailed Description:
This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
Exclusion Criteria:
- of or current medical illness deemed clinically significant by the Investigator (study physician)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343290
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01343290 History of Changes |
| Other Study ID Numbers: | CR018016, 284317541043 |
| Study First Received: | April 1, 2011 |
| Last Updated: | September 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Canagliflozin (JNJ-28431754) Pharmacokinetic Oral Bioavailability Food effect |
ClinicalTrials.gov processed this record on May 23, 2013