HealthyPhase 1NCT02262585
Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
A Phase 1 study testing BIBR 277 tablet and BIBR 277 capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 277 tablet and BIBR 277 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Aug 2002
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >= 20 and <= 35 years
- Weight: BMI > 17.6 and < 26.4 (Weight (kg) / Height (m)2)
- Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
- Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
- History of serious renal disorder
- History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
Show all 21Show fewer
- History of or present cerebrovascular disorder
- History of hyperkalemia
- History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
- History of or present orthostatic hypotension or faint
- Surgery of gastrointestinal tract (except appendectomy)
- History of alcohol or drug abuse
- Participation to another trial with an investigational drug within 4 months prior to the trial
- Whole blood donation more than 400 mL within 3 months prior to the trial
- Whole blood donation more than 100 mL within 1 month prior to the trial
- Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
- Any medication which might influence the result of the trial within 10 days prior to the trial
- Excessive physical activities within 7 days prior to the trial
- Alcohol drinking within 3 days prior to the trial
- Inability to comply with restriction of protocol
- Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
About this study
Official title: Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
- Conditions
- Healthy
- Being tested
- BIBR 277 tablet, BIBR 277 capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 277 tabletDrug
BIBR 277 capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 277 tablet | Experimental | (Mannitol based) Receives: Drug: BIBR 277 tablet |
| BIBR 277 capsule | Active comparator | Not described Receives: Drug: BIBR 277 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum observed concentration of the Telmisartan in plasma)
Measured: up to 72 hours after drug administration
AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
Measured: up to 72 hours after drug administration
Secondary outcomes (9)
Individual time courses of the Telmisartan plasma concentrations
Measured: up to 72 hours after drug administration
tmax (time to reach Cmax)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of the Telmisartan in plasma)
Measured: up to 72 hours after drug administration
AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)
Measured: up to 72 hours after drug administration
MRT0-∞ (total mean residence time of Telmisartan molecules in the body)
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
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 72 hours after drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 72 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 72 hours 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 posted13 Oct 2014 (estimated)
- Study startJul 2002
- Primary completionAug 2002
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
- 30 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
- NCT02262585
- Sponsor's protocol ID
- 502.417
- Status last verified
- Oct 2014
- First submitted
- 9 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
- Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02262585
- Acronym / sponsor ID
- 502.417
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Aug 2002 (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 bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBR 277 tablet | Experimental | Drug: BIBR 277 tablet(Mannitol based) |
| BIBR 277 capsule | Active comparator | Drug: BIBR 277 capsule |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age >= 20 and <= 35 years
- Weight: BMI > 17.6 and < 26.4 (Weight (kg) / Height (m)2)
- Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
- Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
Key exclusion criteria (21 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
- History of serious renal disorder
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 |
|---|---|---|
| BIBR 277 tablet | Drug | BIBR 277 tablet |
| BIBR 277 capsule | Drug | BIBR 277 capsule |
Primary outcome
Cmax (maximum observed concentration of the Telmisartan in plasma)
Time frame: up to 72 hours after drug administration
AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
Time frame: up to 72 hours after drug administration
9 secondary outcomes
Individual time courses of the Telmisartan plasma concentrations
Time frame: up to 72 hours after drug administration
tmax (time to reach Cmax)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the Telmisartan in plasma)
Time frame: up to 72 hours after drug administration
AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)
Time frame: up to 72 hours after drug administration
MRT0-∞ (total mean residence time of Telmisartan molecules in the body)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 72 hours 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 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 BIBR 277 tablet and BIBR 277 capsule 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 21 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?
Cmax (maximum observed concentration of the Telmisartan in plasma) (time frame: up to 72 hours after 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.