A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects
2 other identifiers
interventional
64
1 country
1
Brief Summary
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2011
Shorter than P25 for phase_1 healthy
1 active site
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
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMay 6, 2013
May 1, 2013
2 months
October 17, 2011
May 3, 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 approxmately 23 days
Clinical laboratory tests
Up to approximately 23 days
Vital signs
Up to approximately 23 days
Study Arms (2)
Treatment Sequence AB
EXPERIMENTALTreatment Sequence BA
EXPERIMENTALInterventions
Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Eligibility Criteria
You may qualify if:
- \- Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg
You may not qualify if:
- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tempe, Arizona, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and 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
October 17, 2011
First Posted
October 19, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 6, 2013
Record last verified: 2013-05