- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02071368
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants
June 30, 2014 updated by: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (2 x 500 mg) in Healthy Fed Subjects
The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of a Fixed Dose Combination (FDC) tablets of canagliflozin (CANA) and metformin extended release (MET XR) in comparison with tablets of individual components.
Two FDC tablets will be studied with different formulations of MET XR component (CANA component will be identical).
Both FDCs will be of the same strength: 2 tablets of 150mg CANA/500mg MET XR and will be compared with the equal doses of the individual drugs: canagliflozin (1 x 300mg tablet) and metformin XR (2 x 500mg tablets).
Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components.
Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover).
The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
Study Type
Interventional
Enrollment (Actual)
3
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
-
-
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:
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
- Must have a body weight of not less than 50 kg
- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
Exclusion Criteria:
- History of or current clinically significant medical illness
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
- History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- Known allergy to heparin or history of heparin induced thrombocytopenia
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
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 A
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.
|
Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).
Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
Other Names:
|
Experimental: Treatment B
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC (2 x [150 mg/500 mg]) formulation 1, under fed conditions.
|
Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, to be taken orally.
|
Experimental: Treatment C
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC (2 x [150 mg/500 mg]), formulation 2, under fed conditions.
|
Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, to be taken orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentration of canagliflozin following the single dose of drug administration
Time Frame: Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4
|
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
|
Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4
|
Plasma concentration of metformin extended release following the single dose of drug administration
Time Frame: Day 1 to Day 2 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, and 30 hours postdose); and Day 3 (36 hours)
|
Plasma concentrations of metformin are used to evaluate how long it stays in the body.
|
Day 1 to Day 2 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, and 30 hours postdose); and Day 3 (36 hours)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to Day 10 of the follow-up period
|
Up to Day 10 of the follow-up period
|
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
February 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
February 24, 2014
First Posted (Estimate)
February 25, 2014
Study Record Updates
Last Update Posted (Estimate)
July 1, 2014
Last Update Submitted That Met QC Criteria
June 30, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR103258
- 28431754DIA1063 (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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Canagliflozin, 300 mg
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Janssen Research & Development, LLCCompletedDiabetes Mellitus, Type 2United States, Brazil
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedDiabetes Mellitus, Type 2United States
-
McGill University Health Centre/Research Institute...RecruitingESRD | CKD Stage 4 | CKD Stage 5Canada
-
Janssen Research & Development, LLCThe George Institute for Global Health, AustraliaCompletedDiabetes Mellitus, Type 2 | AlbuminuriaAustralia, France, Italy, Poland, Ukraine, United Kingdom, United States, China, Belgium, Germany, Taiwan, Spain, Argentina, Mexico, Malaysia, Canada, Netherlands, Korea, Republic of, New Zealand, Brazil, Russian Federation, Puerto... and more
-
Janssen Research & Development, LLCCompletedDiabetes Mellitus, Type 1United States, Canada
-
Janssen Research & Development, LLCCompletedDiabetes Mellitus, Type 2United States
-
Janssen Research & Development, LLCCompletedDiabetes Mellitus, Type 2United States, Ukraine, Argentina, Mexico, Romania, South Africa, Korea, Republic of, Russian Federation, Brazil, Puerto Rico, Hungary, Slovakia, Czechia
-
Janssen Research & Development, LLCThe George Institute for Global Health, AustraliaCompletedCardiovascular Diseases | Diabetes Mellitus, Type 2 | Risk FactorsUnited States, Australia, Poland, Ukraine, United Kingdom, Belgium, Germany, France, Spain, Argentina, Colombia, Israel, Mexico, India, Canada, Netherlands, Sweden, Malaysia, New Zealand, Estonia, Russian Federation, Hungary, Norway, ... and more