HealthyPhase 1NCT02028767
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
A Phase 1 study testing Empagliflozin 2.5 mg, Empagliflozin 10 mg and Metformin 500 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Canada.
Trial summary
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Empagliflozin 2.5 mg, Empagliflozin 10 mg and Metformin 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Feb 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests.
- Age 18 to 50 years (inclusive)
- BMI 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation.
Who cannot join
- Any finding in the medical examination (Including blood pressure [BP], pulse rate [PR], or electrocardiogram [ECG]) deviating from normal and judged clinically relevant by the investigator.
- Any evidence of a concomitant disease judged clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders.
- History of relevant orthostatic hypotension, fainting spells, or blackouts.
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- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or it's excipients)
- Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication.
- Within 14 days prior to the administration of trial medication, use of drugs that might reasonably influence the results of the trial, based on current knowledge
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication.
- Smoker (has used tobacco or nicotine-containing products within 6 months prior to administration of trial medication)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or > 7 alcohol-containing drinks per week)
- Drug abuse or positive drug screen
- Blood donation (more than 100 ml wihtin 30 days prior to administration of trial medication or intended during the trial)
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study.
- For female subjects:
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion.
- No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent, surgically sterile, or post menopausal will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide). Post-menopausal is defined as at least 1 year of spontaneous amenorrhea and deemed post menopausal by a physician based on screening clinical laboratory tests (follicle stimulating hormone and luteinizing hormone).
- Lactation
Trial locations and contacts
1 site in 1 country.
Canada1 site
1276.24.001 Boehringer Ingelheim Investigational Site
Toronto, Ontario
About this study
Official title: Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
- Conditions
- Healthy
- Being tested
- Empagliflozin 2.5 mg, Empagliflozin 10 mg, Metformin 500 mg, Empagliflozin/Metformin FDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 2.5 mgDrug
Empagliflozin 2.5 mg tablet
Empagliflozin 10 mgDrug
Empagliflozin 10 mg tablet
Metformin 500 mgDrug
Metformin 500 mg tablet
Empagliflozin/Metformin FDCDrug
12.5 mg Empagliflozin / 500 mg Metformin
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose Combination (FDC) | Experimental | 12.5 mg Empagliflozin / 500mg metformin fixed dose combination Receives: Drug: Empagliflozin/Metformin FDC |
| Separate tablets | Active comparator | Empagliflozin and Metformin tablets Receives: Drug: Empagliflozin 2.5 mg; Drug: Empagliflozin 10 mg; Drug: Metformin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax (Maximum Measured Concentration of Metformin in Plasma)
Cmax (maximum measured concentration of metformin in plasma)
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Secondary outcomes (1)
AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028767
- Sponsor's protocol ID
- 1276.24
- Status last verified
- Jun 2015
- First submitted
- 6 Jan 2014
- Last updated
- 24 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)
- ClinicalTrials.gov ID
- NCT02028767
- Acronym / sponsor ID
- 1276.24
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 24 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose Combination (FDC) | Experimental | Drug: Empagliflozin/Metformin FDC12.5 mg Empagliflozin / 500mg metformin fixed dose combination |
| Separate tablets | Active comparator | Drug: Empagliflozin 2.5 mg, Drug: Empagliflozin 10 mg, Drug: Metformin 500 mgEmpagliflozin and Metformin tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or females according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests.
- Age 18 to 50 years (inclusive)
- BMI 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation.
Key exclusion criteria (23 listed)
- Any finding in the medical examination (Including blood pressure [BP], pulse rate [PR], or electrocardiogram [ECG]) deviating from normal and judged clinically relevant by the investigator.
- Any evidence of a concomitant disease judged clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders.
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 |
|---|---|---|
| Empagliflozin 2.5 mgEmpagliflozin 2.5 mg tablet | Drug | Separate tablets |
| Empagliflozin 10 mgEmpagliflozin 10 mg tablet | Drug | Separate tablets |
| Metformin 500 mgMetformin 500 mg tablet | Drug | Separate tablets |
| Empagliflozin/Metformin FDC12.5 mg Empagliflozin / 500 mg Metformin | Drug | Fixed Dose Combination (FDC) |
Primary outcome
AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)
Cmax (Maximum Measured Concentration of Metformin in Plasma)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
1 secondary outcome
AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 Empagliflozin 2.5 mg, Empagliflozin 10 mg and Metformin 500 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Canada.
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 23 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 24 Jul 2015. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration). 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 24 Jul 2015.