HealthyPhase 1NCT02865668

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

A Phase 1 study testing Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin and Metformin Extended Release (XR) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin and Metformin Extended Release (XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Oct 2016
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: 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

Conditions: Healthy
Being tested: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]Drug
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.
CanagliflozinDrug
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.
Metformin Extended Release (XR)Drug
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.

Study groups in NCT02865668
Study group	Role	What they receive
Treatment Sequence ADBC	Experimental	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. Receives: Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Drug: Canagliflozin; Drug: Metformin Extended Release (XR)
Treatment Sequence BACD	Experimental	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. Receives: Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Drug: Canagliflozin; Drug: Metformin Extended Release (XR)
Treatment Sequence CBDA	Experimental	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. Receives: Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Drug: Canagliflozin; Drug: Metformin Extended Release (XR)
Treatment Sequence DCAB	Experimental	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. Receives: Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Drug: Canagliflozin; Drug: Metformin Extended Release (XR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Metformin
The Cmax is the maximum observed plasma concentration of metformin.
Measured: 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
Area Under the Plasma Concentration Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin
The AUClast is the area under the plasma concentration time curve from time 0 to the time of the last observed quantifiable concentration (Clast).
Measured: 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
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.
Measured: 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

Secondary outcomes (1)

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Measured: Screening to End of study (up to 58 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Oct 2016

First posted12 Aug 2016 (estimated)
Study startAug 2016
Primary completionOct 2016
Study completionOct 2016

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02865668
Sponsor's protocol ID: CR108198
Other IDs: 28431754DIA1073
Status last verified: Jan 2025
First submitted: 10 Aug 2016
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02865668
Acronym / sponsor ID: CR108198
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 12 Aug 2016 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment Sequence ADBC	Experimental	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Drug: Canagliflozin, Drug: Metformin Extended Release (XR)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.
Treatment Sequence BACD	Experimental	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Drug: Canagliflozin, Drug: Metformin Extended Release (XR)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.
Treatment Sequence CBDA	Experimental	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Drug: Canagliflozin, Drug: Metformin Extended Release (XR)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.
Treatment Sequence DCAB	Experimental	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Drug: Canagliflozin, Drug: Metformin Extended Release (XR)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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

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
Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]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.	Drug	Treatment Sequence ADBC, Treatment Sequence BACD, Treatment Sequence CBDA, Treatment Sequence DCAB
CanagliflozinParticipants 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.	Drug	Treatment Sequence ADBC, Treatment Sequence BACD, Treatment Sequence CBDA, Treatment Sequence DCAB
Metformin Extended Release (XR)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.	Drug	Treatment Sequence ADBC, Treatment Sequence BACD, Treatment Sequence CBDA, Treatment Sequence DCAB

Primary outcome

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
The Cmax is the maximum observed plasma concentration of metformin.
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).
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.

1 secondary outcome

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)

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 3 Feb 2025.

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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 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?

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 6 inclusion and 5 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 3 Feb 2025. 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?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02865668.

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 3 Feb 2025.