HealthyPhase 1NCT01463774
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
A Phase 1 study testing Treatment A: Canagliflozin tablet, Treatment A: Metformin IR tablets and Treatment B: Canagliflozin/metformin fixed dose combination tablets in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A: Canagliflozin tablet, Treatment A: Metformin IR tablets and Treatment B: Canagliflozin/metformin fixed dose combination tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pivotal BE CANA/MET IR FDC - Low Strength
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
Read the 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 of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
- Conditions
- Healthy
- Being tested
- Treatment A: Canagliflozin tablet, Treatment A: Metformin IR tablets, Treatment B: Canagliflozin/metformin fixed dose combination tablets
- Keywords
- Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: Canagliflozin tabletDrug
Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.
Treatment A: Metformin IR tabletsDrug
Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.
Treatment B: Canagliflozin/metformin fixed dose combination tabletsDrug
Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. Receives: Drug: Treatment A: Canagliflozin tablet; Drug: Treatment A: Metformin IR tablets; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets |
| Treatment Sequence BA | Experimental | The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. Receives: Drug: Treatment A: Canagliflozin tablet; Drug: Treatment A: Metformin IR tablets; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canagliflozin plasma concentrations
Measured: Up to 72 hours
Metformin plasma concentrations
Measured: Up to 72 hours
Secondary outcomes (3)
Adverse events
The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-15 washout period between treatment periods (total time is approximately 23 days).
Measured: Up to approxmately 23 days
Changes from baseline in clinical laboratory test results
Measured: Up to approximately 23 days
Vital Signs
Blood pressure, pulse, and oral body temperature
Measured: Up to approximately 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC L.LC. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463774
- Sponsor's protocol ID
- CR100674
- Other IDs
- 28431754DIA1039
- Status last verified
- Nov 2012
- First submitted
- 20 Sep 2011
- Last updated
- 21 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal BE CANA/MET IR FDC - Low Strength
- ClinicalTrials.gov ID
- NCT01463774
- Acronym / sponsor ID
- CR100674
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
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 of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: Treatment A: Canagliflozin tablet, Drug: Treatment A: Metformin IR tablets, Drug: Treatment B: Canagliflozin/metformin fixed dose combination tabletsThe study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. |
| Treatment Sequence BA | Experimental | Drug: Treatment A: Canagliflozin tablet, Drug: Treatment A: Metformin IR tablets, Drug: Treatment B: Canagliflozin/metformin fixed dose combination tabletsThe study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A: Canagliflozin tabletType=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Treatment A: Metformin IR tabletsType=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Treatment B: Canagliflozin/metformin fixed dose combination tabletsType=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Canagliflozin plasma concentrations
Time frame: Up to 72 hours
Metformin plasma concentrations
Time frame: Up to 72 hours
3 secondary outcomes
Adverse events
Time frame: Up to approxmately 23 days
Changes from baseline in clinical laboratory test results
Time frame: Up to approximately 23 days
Vital Signs
Time frame: Up to approximately 23 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC L.LC. Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A: Canagliflozin tablet, Treatment A: Metformin IR tablets and Treatment B: Canagliflozin/metformin fixed dose combination tablets in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canagliflozin plasma concentrations (time frame: Up to 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.