HealthyPhase 1NCT02221401
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
A Phase 1 study testing Linagliptin/Metformin FDC, Linagliptin and Metformin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together. 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, Linagliptin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 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 men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead 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 local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating 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) or 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
- Participation 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 women and 30 g/day in men)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
- Any laboratory value outside the reference range of clinical relevance
- Inability to comply with dietary regimen of trial site
- For female subjects of childbearing potential only:
- Positive pregnancy test, pregnancy or planning 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 surgically sterile were asked to use an additional barrier method (e.g. condom).
- Lactation
About this study
Official title: Bioequivalence of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed-dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 1000 mg Tablets Administered Together in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin/Metformin FDCDrug
LinagliptinDrug
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (FDC) | Experimental | Not described Receives: Drug: Linagliptin/Metformin FDC |
| Treatment B (single agents) | Active comparator | Not described Receives: Drug: Linagliptin; Drug: Metformin |
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
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours
Secondary outcomes (15)
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours
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
%AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation)
Measured: up to 72 hours
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
tmax (time from dosing until maximum concentration of the analyte in plasma)
Measured: up to 72 hours
λz (terminal elimination rate constant in plasma)
Measured: up to 72 hours
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours
MRTpo (mean residence time of the analyte in the body after peroral administration)
Measured: up to 72 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 72 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to 7 days after last drug administration
Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG)
Measured: up to 7 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 7 days after last drug administration
Number of subjects with adverse events
Measured: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 7 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJan 2010
- Primary completionApr 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
- 96 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
- NCT02221401
- Sponsor's protocol ID
- 1288.1
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed-dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 1000 mg Tablets Administered Together in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
- ClinicalTrials.gov ID
- NCT02221401
- Acronym / sponsor ID
- 1288.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- First posted
- 20 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 demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (FDC) | Experimental | Drug: Linagliptin/Metformin FDC |
| Treatment B (single agents) | Active comparator | Drug: Linagliptin, Drug: Metformin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead 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 local legislation
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating 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) or 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 | Treatment A (FDC) |
| Linagliptin | Drug | Treatment B (single agents) |
| Metformin | Drug | Treatment B (single agents) |
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
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours
15 secondary outcomes
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours
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
%AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation)
Time frame: up to 72 hours
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
tmax (time from dosing until maximum concentration of the analyte in plasma)
Time frame: up to 72 hours
λz (terminal elimination rate constant in plasma)
Time frame: up to 72 hours
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours
MRTpo (mean residence time of the analyte in the body after peroral administration)
Time frame: up to 72 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 72 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours
Number of subjects with clinically significant findings in vital signs
Time frame: up to 7 days after last drug administration
Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 7 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 7 days after last drug administration
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 7 days after last 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 20 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, Linagliptin and Metformin 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 20 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). 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 20 Aug 2014.