HealthyPhase 1NCT02262793
Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects
A Phase 1 study testing telmisartan and ASA/ER-DP in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1)… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- telmisartan and ASA/ER-DP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jul 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females and males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 27Show fewer
- 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 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/day or 3 cigars/day or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one 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 study centre
- History of hereditary fructose intolerance
- History of any familial bleeding disorder
- 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 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 in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male Subjects
To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).
To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).
- Conditions
- Healthy
- Being tested
- telmisartan, ASA/ER-DP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
ASA/ER-DPDrug
| Study group | Role | What they receive |
|---|---|---|
| telmisartan and ASA/ER-DP (concomitant) | Experimental | Not described Receives: Drug: telmisartan; Drug: ASA/ER-DP |
| ASA/ER-DP alone | Active comparator | Not described Receives: Drug: ASA/ER-DP |
| telmisartan and ASA/ER-DP (consecutively) | Experimental | Not described Receives: Drug: telmisartan; Drug: ASA/ER-DP |
| telmisartan | Active comparator | Not described Receives: Drug: telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration time curve in plasma from 0 extrapolated to infinity)
Measured: up to 72 hours following drug administration
Cmax (maximum concentration in plasma)
Measured: up to 72 hours following drug administration
Secondary outcomes (13)
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours following drug administration
AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
Measured: up to 72 hours following drug administration
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Measured: up to 72 hours following drug administration
λz (terminal rate constant in plasma)
Measured: up to 72 hours following drug administration
t1/2 (terminal half-life of the analytes in plasma)
Measured: up to 72 hours following drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Measured: up to 72 hours following drug administration
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Measured: up to 72 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours following drug administration
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
blood pressure, heart rate
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in 12 lead ECG
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 8 days after last drug administration
Assessment of tolerability by the investigator on a 4-point scale
Measured: up to 8 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 posted13 Oct 2014 (estimated)
- Study startMay 2004
- Primary completionJul 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
- NCT02262793
- Sponsor's protocol ID
- 502.458
- 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 in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male Subjects
- ClinicalTrials.gov ID
- NCT02262793
- Acronym / sponsor ID
- 502.458
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 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.
To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).
To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® 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 and ASA/ER-DP (concomitant) | Experimental | Drug: telmisartan, Drug: ASA/ER-DP |
| ASA/ER-DP alone | Active comparator | Drug: ASA/ER-DP |
| telmisartan and ASA/ER-DP (consecutively) | Experimental | Drug: telmisartan, Drug: ASA/ER-DP |
| telmisartan | Active comparator | Drug: telmisartan |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy females and males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- 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 (27 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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
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, telmisartan and ASA/ER-DP (concomitant), telmisartan and ASA/ER-DP (consecutively) |
| ASA/ER-DP | Drug | ASA/ER-DP alone, telmisartan and ASA/ER-DP (concomitant), telmisartan and ASA/ER-DP (consecutively) |
Primary outcome
AUC0-∞ (area under the concentration time curve in plasma from 0 extrapolated to infinity)
Time frame: up to 72 hours following drug administration
Cmax (maximum concentration in plasma)
Time frame: up to 72 hours following drug administration
13 secondary outcomes
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours following drug administration
AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
Time frame: up to 72 hours following drug administration
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 72 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours following drug administration
t1/2 (terminal half-life of the analytes in plasma)
Time frame: up to 72 hours following drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Time frame: up to 72 hours following drug administration
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 72 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours following drug administration
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 12 lead ECG
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Assessment of tolerability by the investigator on a 4-point scale
Time frame: up to 8 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 13 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 ASA/ER-DP 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 7 inclusion and 27 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 in plasma from 0 extrapolated to infinity) (time frame: up to 72 hours following 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 13 Oct 2014.