HealthyPhase 1NCT02223026
Relative Bioavailability of a Linagliptin+Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects
A Phase 1 study testing Linagliptin/metformin FDC and high-fat, high caloric meal in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet 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?
- Linagliptin/metformin FDC and high-fat, high caloric meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2010
- 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
- Healthy males and females according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age 18 to 55 years (inclusive)
- Body mass index (BMI) of 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 the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR, and ECG) which deviated from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
Show all 20Show fewer
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
- Participated in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
- Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of trial site
- For female subjects of childbearing potential only:
- Positive pregnancy test, pregnancy, or had planned to become pregnant during the study or within 2 months after study completion
- No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent, or were not surgically sterile were asked to use an additional barrier method (e.g. condom)
- Lactation
About this study
Official title: Relative Bioavailability of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-way Crossover, Phase I Trial
Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet
- Conditions
- Healthy
- Being tested
- Linagliptin/metformin FDC, high-fat, high caloric meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin/metformin FDCDrug
high-fat, high caloric mealOther
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin/metformin fed | Experimental | Not described Receives: Drug: Linagliptin/metformin FDC; Other: high-fat, high caloric meal |
| Linagliptin/metformin fasted | Active comparator | Not described Receives: Drug: Linagliptin/metformin FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
Measured: up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 h extrapolated to infinity)
Measured: up to 72 hours after drug administration
Secondary outcomes (14)
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 h extrapolated to infinity)
Measured: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours after drug administration
AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Measured: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
λz (terminal elimination rate constant in plasma)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to 7 days after drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 7 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 7 days after drug administration
Number of subjects with adverse events
Measured: up to 7 days after drug administration
Assessment of tolerability by the investigator on a 4-point scale
Measured: up to 7 days 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 posted22 Aug 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2010
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 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
- Treatment
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223026
- Sponsor's protocol ID
- 1288.4
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-way Crossover, Phase I Trial
- ClinicalTrials.gov ID
- NCT02223026
- Acronym / sponsor ID
- 1288.4
- 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 2010
- Primary completion
- Mar 2010 (actual)
- First posted
- 22 Aug 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.
Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin/metformin fed | Experimental | Drug: Linagliptin/metformin FDC, Other: high-fat, high caloric meal |
| Linagliptin/metformin fasted | Active comparator | Drug: Linagliptin/metformin FDC |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age 18 to 55 years (inclusive)
- Body mass index (BMI) of 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 the local legislation
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including BP, PR, and ECG) which deviated from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological 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 |
|---|---|---|
| Linagliptin/metformin FDC | Drug | Linagliptin/metformin fasted, Linagliptin/metformin fed |
| high-fat, high caloric meal | Other | Linagliptin/metformin fed |
Primary outcome
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
Time frame: up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 h extrapolated to infinity)
Time frame: up to 72 hours after drug administration
14 secondary outcomes
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 h extrapolated to infinity)
Time frame: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after drug administration
AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
λz (terminal elimination rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 7 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 7 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 7 days after drug administration
Number of subjects with adverse events
Time frame: up to 7 days after drug administration
Assessment of tolerability by the investigator on a 4-point scale
Time frame: up to 7 days after drug administration
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 22 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Linagliptin/metformin FDC and high-fat, high caloric meal in people with Healthy, run by Boehringer Ingelheim.
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 20 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h) (time frame: up to 72 hours after drug administration). 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?
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 22 Aug 2014.