Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers
Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with 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 Oct 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 20, 2013
February 1, 2013
2 months
October 21, 2011
February 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Canagliflozin plasma concentrations
Up to 72 hours
Metformin plasma concentrations
Up to 24 hours
Secondary Outcomes (3)
Adverse events
Up to approximately 22 days
Clinical Laboratory Tests
Up to approximately 22 days
Vital Signs
Up to approximately 22 days
Study Arms (2)
Treatment Sequence AB
EXPERIMENTALTreatment Sequence BA
EXPERIMENTALInterventions
Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.
Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Murphy J, Wang SS, Stieltjes H, Wajs E, Devineni D. Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants. Int J Clin Pharmacol Ther. 2015 Mar;53(3):256-64. doi: 10.5414/CP202233.
PMID: 25546166DERIVED
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC L.LC. Clinical Trial
Janssen Research & Development, LLC
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
October 21, 2011
First Posted
October 25, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 20, 2013
Record last verified: 2013-02