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

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ClinicalTrials.gov Identifier: NCT01343290
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Canagliflozin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Concentration of canagliflozin in plasma samples [ Time Frame: For up to 8 days ]

Secondary Outcome Measures :
  1. Adverse events reported [ Time Frame: Up to approximately 34 days ]
  2. Vital signs measurements [ Time Frame: Up to approximately 34 days ]
  3. Results from clinical chemistries performed [ Time Frame: Up to approximately 34 days ]
  4. Results from 12-lead ECGs performed [ Time Frame: Up to approximately 34 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01343290     History of Changes
Other Study ID Numbers: CR018016
284317541043
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: September 2012

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin (JNJ-28431754)
Pharmacokinetic
Oral Bioavailability
Food effect

Additional relevant MeSH terms:
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs