Healthy VolunteersPhase 1NCT02073227
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
A Phase 1 study testing Canagliflozin, 300 mg, Metformin XR, 500 mg and CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the bioequivalence 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/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Canagliflozin, 300 mg, Metformin XR, 500 mg and CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2014
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects
The purpose of this study is to assess the bioequivalence 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/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.
Read the 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 are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).
The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; 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 the 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, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
- Conditions
- Healthy Volunteers
- Being tested
- Canagliflozin, 300 mg, Metformin XR, 500 mg, CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg, CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg
- Keywords
- Healthy Volunteers, Canagliflozin, Metformin, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin, 300 mgDrug
Also called INVOKANA™
Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).
Metformin XR, 500 mgDrug
Also called GLUMETZA®
Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mgDrug
Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.
CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mgDrug
Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 4 tablets of metformin extended release (MET XR), 500 mg each, administered together under fed conditions. Receives: Drug: Canagliflozin, 300 mg; Drug: Metformin XR, 500 mg |
| Treatment B | Experimental | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions. Receives: Drug: CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg |
| Treatment C | Experimental | Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions. Receives: Drug: CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of canagliflozin following administration of a single dose of study drug
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Measured: Predose, (before tablet intake) up to 72 hours after dose
Plasma concentration of metformin following administration of a single dose of study drug
Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
Measured: Predose, up to 36 hours after dose
Secondary outcomes (1)
Percentage of participants with adverse events as a measure of safety and tolerability
Measured: Screening, up to Day 10 of the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 52 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 Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073227
- Sponsor's protocol ID
- CR103256
- Other IDs
- 28431754DIA1044
- Status last verified
- Sep 2014
- First submitted
- 25 Feb 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects
- ClinicalTrials.gov ID
- NCT02073227
- Acronym / sponsor ID
- CR103256
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Canagliflozin, Metformin, Type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Feb 2014 (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 assess the bioequivalence 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/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.
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 are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).
The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; 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 the 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, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Canagliflozin, 300 mg, Drug: Metformin XR, 500 mgEach participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 4 tablets of metformin extended release (MET XR), 500 mg each, administered together under fed conditions. |
| Treatment B | Experimental | Drug: CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mgEach participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions. |
| Treatment C | Experimental | Drug: CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mgEach participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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, 300 mgAlso: INVOKANA™Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth). | Drug | Treatment A |
| Metformin XR, 500 mgAlso: GLUMETZA®Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth). | Drug | Treatment A |
| CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mgEach tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally. | Drug | Treatment B |
| CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mgEach tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally. | Drug | Treatment C |
Primary outcome
Plasma concentration of canagliflozin following administration of a single dose of study drug
Time frame: Predose, (before tablet intake) up to 72 hours after dose
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Plasma concentration of metformin following administration of a single dose of study drug
Time frame: Predose, up to 36 hours after dose
Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
1 secondary outcome
Percentage of participants with adverse events as a measure of safety and tolerability
Time frame: Screening, up to Day 10 of the follow-up period
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 9 Sep 2014.
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Healthy Participants
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?
A Phase 1 study testing Canagliflozin, 300 mg, Metformin XR, 500 mg and CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg in people with Healthy Volunteers, 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 4 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 9 Sep 2014. 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?
Plasma concentration of canagliflozin following administration of a single dose of study drug (time frame: Predose, (before tablet intake) up to 72 hours after dose). 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 9 Sep 2014.