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The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers

This study has been completed.
Sponsor:
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

April 1, 2011
September 29, 2012
April 2011
June 2011   (final data collection date for primary outcome measure)
Concentration of canagliflozin in plasma samples [ Time Frame: For up to 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01343290 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
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
Intervention: Drug: Canagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01343290
CR018016, 284317541043
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP