- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865668
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
February 8, 2017 updated by: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (50 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy fed and fasted participants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
44
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
-
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Arizona
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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:
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- Before randomization, a woman must be either Not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly) throughout the study
- All women must have a negative urine pregnancy test at Screening and on Day -1 of each Treatment Period
- Body mass index (BMI) (weight [kg]/height^2 [m]2) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg)
- Blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, systolic and no higher than 90 mmHg diastolic at Screening or Day -1 of each Treatment Period
- Normal renal function evidenced by estimated glomerular filtration rate (eGFR) >=90 milliliters per minute (mL/min)/1.73m2 using the Modification of Diet in Renal Disease Study (MDRD) equation as defined in the protocol
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis as assessed by the investigator at Screening or Day -1 of the first Treatment Period
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) (Screening only) as assessed by the investigator at Screening or on Day -1 of the first Treatment Period as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, hormonal contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence BACD
Participants will receive Treatment B on Day 1 of treatment period 1, then Treatment A on Day 1 of treatment period 2, then Treatment C on Day 1 of treatment period 3, followed by Treatment D on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
|
Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
|
Experimental: Treatment Sequence CBDA
Participants will receive Treatment C Day 1 of treatment period 1, then Treatment B on Day 1 of treatment period 2, then Treatment D on Day 1 of treatment period 3, followed by Treatment A on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
|
Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
|
Experimental: Treatment Sequence DCAB
Participants will receive Treatment D on Day 1 of treatment period 1, then Treatment C on Day 1 of treatment period 2, then Treatment A on Day 1 of treatment period 3, followed by Treatment B on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
|
Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
|
Experimental: Treatment Sequence ADBC
Participants will receive Treatment A (1 canagliflozin tablet 50 milligram (mg) along with one Extended Release (XR) tablet of metformin of 500 mg orally under fed condition) on Day 1 of treatment period 1, then Treatment D (1 XR fixed dose combination [FDC] tablet containing canagliflozin 50 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, then Treatment B (1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, followed by Treatment C (1 canagliflozin tablet 50 mg along with one metformin (XR) tablets of 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
|
Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin
Time Frame: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2
|
The AUClast is the area under the plasma concentration time curve from time 0 to the time of the last observed quantifiable concentration (Clast).
|
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2
|
Area Under the Plasma Concentration Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin
Time Frame: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2
|
The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
|
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2
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Maximum Observed Plasma Concentration (Cmax) of Metformin
Time Frame: Predose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr postdose on Day 1; 24 hr postdose on Day 2
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The Cmax is the maximum observed plasma concentration of metformin.
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Predose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr postdose on Day 1; 24 hr postdose on Day 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: Screening to End of study (up to 58 Days)
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Screening to End of study (up to 58 Days)
|
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
August 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
August 10, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 12, 2016
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108198
- 28431754DIA1073 (Other Identifier: Janssen Research & Development, LLC)
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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