HealthyPhase 1NCT02183636
Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects
A Phase 1 study testing Linagliptin/pioglitazone, FDC formulation C5, Linagliptin/pioglitazone, FDC formulation C8 and Linagliptin tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone 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/pioglitazone, FDC formulation C5, Linagliptin/pioglitazone, FDC formulation C8 and Linagliptin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2009
- 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 male and female subjects according to the following criteria: based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age ≥18 and ≤55 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study, in accordance with GCP and the 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), psychiatric disorders, or neurological disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
Show all 24Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (>24 h) within at least 1 month or less than 10 halflives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 30 g/day for males and 20 g/day for females)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- For female subjects:
- Pregnancy or a positive pregnancy test, planning to become pregnant during the study, or within 1 month of study completion or lactation period
- No adequate contraception during the study and until 1 month after study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month before enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females who did not have a vasectomised partner, were not sexually abstinent, or were not surgically sterile were asked to additionally use barrier contraception methods (i.e. condom, diaphragm with spermicide)
- For male subjects:
- Male subjects who did not agree to minimise the risk of female partners becoming pregnant from the first dosing day until the completion of the post study medical examination. Acceptable methods of contraception included barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least 2 months)
About this study
Official title: Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin 5 mg/Pioglitazone 45 mg Compared With Single Linagliptin 5 mg and Pioglitazone 45 mg Tablets Administered Together to Healthy Male and Female Subjects (Open, Randomised, Single Dose, Three-period Crossover Phase I Trial)
Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone administered together
- Conditions
- Healthy
- Being tested
- Linagliptin/pioglitazone, FDC formulation C5, Linagliptin/pioglitazone, FDC formulation C8, Linagliptin tablet, pioglitazone tablet (Actos®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin/pioglitazone, FDC formulation C5Drug
film coated tablet (5 mg/45 mg)
Linagliptin/pioglitazone, FDC formulation C8Drug
film coated tablet (5 mg/45 mg)
Linagliptin tabletDrug
5 mg
pioglitazone tablet (Actos®)Drug
45 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 (T1) | Experimental | Linagliptin/pioglitazone, FDC formulation C5 Receives: Drug: Linagliptin/pioglitazone, FDC formulation C5 |
| Treatment 2 (T2) | Experimental | Linagliptin/pioglitazone, FDC formulation C8 Receives: Drug: Linagliptin/pioglitazone, FDC formulation C8 |
| Reference (R) | Active comparator | Linagliptin tablet and pioglitazone tablet (Actos®) Receives: Drug: Linagliptin tablet; Drug: pioglitazone tablet (Actos®) |
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: 1 hour prior drug administration and up to 120 h after drug administration
Cmax (maximum measured concentration of linagliptin in plasma)
Measured: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 extrapolated to infinity)
Measured: 1 hour prior drug administration and up to 72 h after drug administration
Cmax (maximum measured concentration of pioglitazone in plasma)
Measured: 1 hour prior drug administration and up to 72 h after drug administration
Secondary outcomes (6)
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: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Measured: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-72 (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 to 72 h)
Measured: 1 hour prior drug administration and up to 72 after drug administration
Changes from baseline in vital signs (blood pressure (BP) and pulse rate (PR))
Measured: 21 to 1 day prior start of treatment, at study visits 2 to 4 (prior to treatment administration and 24 h following treatment administration), and 7 days after last treatment administration
Occurrence of adverse events (AEs)
Measured: until 7 days after last treatment administration
Assessment of tolerability by the investigator
Measured: on day 6 of each treatment and 7 days after last treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2009
- Primary completionDec 2009
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
- 39 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
- NCT02183636
- Sponsor's protocol ID
- 1264.1
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin 5 mg/Pioglitazone 45 mg Compared With Single Linagliptin 5 mg and Pioglitazone 45 mg Tablets Administered Together to Healthy Male and Female Subjects (Open, Randomised, Single Dose, Three-period Crossover Phase I Trial)
- ClinicalTrials.gov ID
- NCT02183636
- Acronym / sponsor ID
- 1264.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 8 Jul 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.
Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone administered together
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 (T1) | Experimental | Drug: Linagliptin/pioglitazone, FDC formulation C5Linagliptin/pioglitazone, FDC formulation C5 |
| Treatment 2 (T2) | Experimental | Drug: Linagliptin/pioglitazone, FDC formulation C8Linagliptin/pioglitazone, FDC formulation C8 |
| Reference (R) | Active comparator | Drug: Linagliptin tablet, Drug: pioglitazone tablet (Actos®)Linagliptin tablet and pioglitazone tablet (Actos®) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects according to the following criteria: based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age ≥18 and ≤55 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study, in accordance with GCP and the local legislation
Key exclusion criteria (24 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), 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/pioglitazone, FDC formulation C5film coated tablet (5 mg/45 mg) | Drug | Treatment 1 (T1) |
| Linagliptin/pioglitazone, FDC formulation C8film coated tablet (5 mg/45 mg) | Drug | Treatment 2 (T2) |
| Linagliptin tablet5 mg | Drug | Reference (R) |
| pioglitazone tablet (Actos®)45 mg | Drug | Reference (R) |
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: 1 hour prior drug administration and up to 120 h after drug administration
Cmax (maximum measured concentration of linagliptin in plasma)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 1 hour prior drug administration and up to 72 h after drug administration
Cmax (maximum measured concentration of pioglitazone in plasma)
Time frame: 1 hour prior drug administration and up to 72 h after drug administration
6 secondary outcomes
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: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-72 (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 to 72 h)
Time frame: 1 hour prior drug administration and up to 72 after drug administration
Changes from baseline in vital signs (blood pressure (BP) and pulse rate (PR))
Time frame: 21 to 1 day prior start of treatment, at study visits 2 to 4 (prior to treatment administration and 24 h following treatment administration), and 7 days after last treatment administration
Occurrence of adverse events (AEs)
Time frame: until 7 days after last treatment administration
Assessment of tolerability by the investigator
Time frame: on day 6 of each treatment and 7 days after last treatment 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 8 Jul 2014.
- 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.
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/pioglitazone, FDC formulation C5, Linagliptin/pioglitazone, FDC formulation C8 and Linagliptin tablet 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 24 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 8 Jul 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: 1 hour prior drug administration and up to 120 h after drug administration). The study lists 4 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 8 Jul 2014.