HealthyPhase 1NCT01508182
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers
A Phase 1 study testing Canagliflozin tablets, Metformin IR tablets and Canagliflozin/metformin IR FDC 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 fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR). 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 tablets, Metformin IR tablets and Canagliflozin/metformin IR FDC tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2012
- 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
- 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: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR Tablets (2x500 mg) in Healthy Fed Subjects
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (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 (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.
- Conditions
- Healthy
- Being tested
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Keywords
- Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin IR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin tabletsDrug
Also called Treatment A (Reference)
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
Metformin IR tabletsDrug
Also called Treatment A (Reference)
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Canagliflozin/metformin IR FDC tabletsDrug
Also called Treatment B (Test)
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
Canagliflozin tabletsDrug
Also called Treatment A (Reference)
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
Metformin IR tabletsDrug
Also called Treatment A (Reference)
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Canagliflozin/metformin IR FDC tabletsDrug
Also called Treatment B (Test)
Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. Receives: Drug: Canagliflozin tablets; Drug: Metformin IR tablets; Drug: Canagliflozin/metformin IR FDC tablets |
| Treatment Sequence BA | Experimental | Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. Receives: Drug: Canagliflozin tablets; Drug: Metformin IR tablets; Drug: Canagliflozin/metformin IR FDC 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 in Treatment Period 1 and Treatment Period 2
Metformin plasma concentrations
Measured: Up to 24 hours in Treatment Period 1 and Treatment Period 2
Secondary outcomes (5)
Changes in clinical laboratory test values
Measured: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in vital signs measurements
Measured: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in electrocardiogram (ECG) parameters
Measured: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in physical examination results
Measured: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
The number of patients reporting adverse events
Measured: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
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
- 64 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.L.C Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508182
- Sponsor's protocol ID
- CR100679
- Other IDs
- 28431754DIA1050
- Status last verified
- Jan 2013
- First submitted
- 9 Jan 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR Tablets (2x500 mg) in Healthy Fed Subjects
- ClinicalTrials.gov ID
- NCT01508182
- Acronym / sponsor ID
- CR100679
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin IR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jan 2012 (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 fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (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 (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.
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: Canagliflozin tablets, Drug: Metformin IR tablets, Drug: Canagliflozin/metformin IR FDC tabletsTreatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. |
| Treatment Sequence BA | Experimental | Drug: Canagliflozin tablets, Drug: Metformin IR tablets, Drug: Canagliflozin/metformin IR FDC tabletsTreatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods. |
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| Canagliflozin tabletsAlso: Treatment A (Reference)Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1. | Drug | Treatment Sequence AB |
| Metformin IR tabletsAlso: Treatment A (Reference)Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1. | Drug | Treatment Sequence AB |
| Canagliflozin/metformin IR FDC tabletsAlso: Treatment B (Test)Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2. | Drug | Treatment Sequence AB |
| Canagliflozin tabletsAlso: Treatment A (Reference)Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2. | Drug | Treatment Sequence BA |
| Metformin IR tabletsAlso: Treatment A (Reference)Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2. | Drug | Treatment Sequence BA |
| Canagliflozin/metformin IR FDC tabletsAlso: Treatment B (Test)Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1. | Drug | Treatment Sequence BA |
Primary outcome
Canagliflozin plasma concentrations
Time frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2
Metformin plasma concentrations
Time frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2
5 secondary outcomes
Changes in clinical laboratory test values
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in vital signs measurements
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in electrocardiogram (ECG) parameters
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in physical examination results
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
The number of patients reporting adverse events
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
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 16 Jan 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.L.C 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 tablets, Metformin IR tablets and Canagliflozin/metformin IR FDC 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 16 Jan 2013. 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 in Treatment Period 1 and Treatment Period 2). 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 16 Jan 2013.