HealthyPhase 1NCT02262650
Relative Bioavailability of Telmisartan and SR26334 After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After Administration of Telmisartan and Clopidogrel Alone in Healthy Male and Female Subjects
A Phase 1 study testing Telmisartan and Clopidogrel in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to May 2004
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects according to the following criteria: based upon a complete medical history, the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 40 years
- Body Mass Index (BMI) >=18.5 and <=29.9 kg/m2
- Good venous status of forearms
Who cannot join
- Any finding of the medical examination (including blood pressure, heart rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of 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
- Chronic or relevant acute infections
Show all 26Show fewer
- History of an allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of any drugs, which might reasonably influence the results of the trial 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 two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or three cigars or three pipes/day)
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation or loss of more than 400 mL within four weeks prior to administration or during the trial.
- Excessive physical activities (within five days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- History of hereditary fructose intolerance
- Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
- Inability to comply with the dietary regimen of study centre
- Inability to comply with the investigators instructions
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Relative Bioavailability of Telmisartan and SR26334, the Main Metabolite of Clopidogrel, After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After p.o. Administration of 80 mg Telmisartan and 75 mg Clopidogrel Alone. A Four-way, Single Dose, Open, Randomised Crossover Study in 24 Healthy Male and Female Subjects
Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)
- Conditions
- Healthy
- Being tested
- Telmisartan, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan alone | Active comparator | Not described Receives: Drug: Telmisartan |
| Telmisartan + Clopidogrel (concomitantly) | Experimental | Not described Receives: Drug: Telmisartan; Drug: Clopidogrel |
| Telmisartan + Clopidogrel (consecutively) | Experimental | Not described Receives: Drug: Telmisartan; Drug: Clopidogrel |
| Clopidogrel alone | Active comparator | Not described Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours post dose
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 72 hours post dose
Secondary outcomes (12)
Number of subjects with adverse events
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in labortory test
Measured: up to 8 days after last drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 72 hours post dose
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours post dose
λz (terminal rate constant in plasma)
Measured: up to 72 hours post dose
t1/2 (terminal half-life of the analytes in plasma)
Measured: up to 72 hours post dose
MRTpo (mean residence time of the analytes in the body after po administration)
Measured: up to 72 hours post dose
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Measured: up to 72 hours post dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours post dose
CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2)
Measured: up to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2004
- Primary completionMay 2004
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
- 24 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
- NCT02262650
- Sponsor's protocol ID
- 502.457
- Status last verified
- Oct 2014
- First submitted
- 10 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Telmisartan and SR26334, the Main Metabolite of Clopidogrel, After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After p.o. Administration of 80 mg Telmisartan and 75 mg Clopidogrel Alone. A Four-way, Single Dose, Open, Randomised Crossover Study in 24 Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02262650
- Acronym / sponsor ID
- 502.457
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- May 2004 (actual)
- First posted
- 13 Oct 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 relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telmisartan alone | Active comparator | Drug: Telmisartan |
| Telmisartan + Clopidogrel (concomitantly) | Experimental | Drug: Telmisartan, Drug: Clopidogrel |
| Telmisartan + Clopidogrel (consecutively) | Experimental | Drug: Telmisartan, Drug: Clopidogrel |
| Clopidogrel alone | Active comparator | Drug: Clopidogrel |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects according to the following criteria: based upon a complete medical history, the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 40 years
- Body Mass Index (BMI) >=18.5 and <=29.9 kg/m2
- Good venous status of forearms
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including blood pressure, heart rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of 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
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 |
|---|---|---|
| Telmisartan | Drug | Telmisartan + Clopidogrel (concomitantly), Telmisartan + Clopidogrel (consecutively), Telmisartan alone |
| Clopidogrel | Drug | Clopidogrel alone, Telmisartan + Clopidogrel (concomitantly), Telmisartan + Clopidogrel (consecutively) |
Primary outcome
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours post dose
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 72 hours post dose
12 secondary outcomes
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in labortory test
Time frame: up to 8 days after last drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours post dose
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours post dose
λz (terminal rate constant in plasma)
Time frame: up to 72 hours post dose
t1/2 (terminal half-life of the analytes in plasma)
Time frame: up to 72 hours post dose
MRTpo (mean residence time of the analytes in the body after po administration)
Time frame: up to 72 hours post dose
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 72 hours post dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours post dose
CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2)
Time frame: up to 72 hours post dose
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 13 Oct 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 Telmisartan and Clopidogrel 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 5 inclusion and 26 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 13 Oct 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-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 72 hours post dose). 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 13 Oct 2014.