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
2 other identifiers
interventional
24
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2011
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 2, 2012
September 1, 2012
2 months
April 1, 2011
September 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of canagliflozin in plasma samples
For up to 8 days
Secondary Outcomes (4)
Adverse events reported
Up to approximately 34 days
Vital signs measurements
Up to approximately 34 days
Results from clinical chemistries performed
Up to approximately 34 days
Results from 12-lead ECGs performed
Up to approximately 34 days
Study Arms (1)
001
EXPERIMENTALCanagliflozin Type = 1 unit = mg number = 300 form = tablet route = oral use. Single tablet taken with or without a meal during 2 treatment periods
Interventions
Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods
Eligibility Criteria
You may qualify if:
- Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
You may not qualify if:
- of or current medical illness deemed clinically significant by the Investigator (study physician)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27136908DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 28, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
October 2, 2012
Record last verified: 2012-09