- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508182
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers
January 15, 2013 updated by: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR Tablets (2x500 mg) in Healthy Fed Subjects
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 the FDC tablets (canagliflozin and metformin IR).
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B).
Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
The total duration of the study will be approximately 51 days.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence AB
Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods.
|
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use.
One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
Other Names:
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use.
Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Other Names:
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use.
Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
Other Names:
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use.
One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
Other Names:
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use.
Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Other Names:
Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use.
Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
Other Names:
|
Experimental: Treatment Sequence BA
Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods.
|
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use.
One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
Other Names:
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use.
Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Other Names:
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use.
Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
Other Names:
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use.
One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
Other Names:
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use.
Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Other Names:
Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use.
Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Canagliflozin plasma concentrations
Time Frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2
|
Up to 72 hours in Treatment Period 1 and Treatment Period 2
|
Metformin plasma concentrations
Time Frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2
|
Up to 24 hours in Treatment Period 1 and Treatment Period 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in clinical laboratory test values
Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Changes in vital signs measurements
Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Changes in electrocardiogram (ECG) parameters
Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Changes in physical examination results
Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
The number of patients reporting adverse events
Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
January 9, 2012
First Submitted That Met QC Criteria
January 10, 2012
First Posted (Estimate)
January 11, 2012
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100679
- 28431754DIA1050 (Other Identifier: Janssen Research & Development)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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