Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers

October 9, 2014 updated by: Boehringer Ingelheim

Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers

Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >= 20 and <= 35 years
  2. Weight: BMI >= 17.6 and <= 26.4 (Weight (kg) / Height (m)2)
  3. Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
  4. Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  3. Chronic or relevant acute infections
  4. History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
  5. History of serious renal disorder
  6. History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
  7. History of or present cerebrovascular disorder
  8. History of hyperkalemia
  9. History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
  10. History of or present orthostatic hypotension or faint
  11. Surgery of gastrointestinal tract (except appendectomy)
  12. History of alcohol or drug abuse
  13. Participation to another trial with an investigational drug within 4 months prior to the trial
  14. Whole blood donation more than 400 mL within 3 months prior to the trial
  15. Whole blood donation more than 100 mL within 1 month prior to the trial
  16. Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
  17. Any medication which might influence the result of the trial within 10 days prior to the trial
  18. Excessive physical activities within 7 days prior to the trial
  19. Alcohol drinking within 3 days prior to the trial
  20. Inability to comply with restriction of protocol
  21. Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BIBR 277 tablet
Drug: BIBR 277 tablet
Other Names:
  • Telmisartan
ACTIVE_COMPARATOR: BIBR 277 capsule
Drug: BIBR 277 capsule
Other Names:
  • Telmisartan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax (maximum observed concentration of the Telmisartan in plasma)
Time Frame: up to 72 hours after drug administration
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
up to 72 hours after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Individual time courses of the Telmisartan plasma concentrations
Time Frame: up to 72 hours after drug administration
up to 72 hours after drug administration
tmax (time to reach Cmax)
Time Frame: up to 72 hours after drug administration
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
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
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
up to 72 hours after drug administration
Number of subjects with adverse events
Time Frame: up to 72 hours after last drug administration
up to 72 hours after last drug administration
Number of subjects with clinically significant findings in vital signs
Time Frame: up to 72 hours after last drug administration
blood pressure, pulse rate
up to 72 hours after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to 72 hours after last drug administration
up to 72 hours after last drug administration
Number of subjects with clinically significant findings in ECG
Time Frame: up to 72 hours after last drug administration
up to 72 hours after last drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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