- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223000
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
August 21, 2014 updated by: Boehringer Ingelheim
Relative Bioavailability and Tolerability of Various Experimental Formulations of 50 mg BIBV 308 SE Administered Orally Twice a Day Over 3.5 Days to Healthy Subjects (Intraindividual Comparison, Open, Partially Randomised).
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- 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
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 55 years
- Broca >= -20% and <= +20 %
Exclusion Criteria:
- Poor individual absorption kinetics of BIBV 308 SE in previous studies
- Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- Hypersensitivity to BIBV 308 SE and any of the excipients
- Intake of drugs with a long half-life (> 24 hours) <= 1 month prior to administration or during the trial
- Use of any drugs which might influence the results of the trial <= 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug <= 2 months days prior to administration or during the trial
- Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
- Inability to refrain from smoking on study days
- Known alcohol or drug abuse
- Blood donation <= 1 month prior to administration
- Excessive physical activities <= 5 days prior to administration
- History of hemorrhagic diathesis
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- Any laboratory value outside the reference range of clinical relevance
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BIBV 308 SE solution
|
|
Experimental: BIBV 308 SE capsule 1
|
|
Experimental: BIBV 308 SE capsule 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent peak-trough fluctuation (%PTF)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Mean residence time of the analyte in the body (MRTtot)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Apparent clearance of the analyte in plasma (CL/f)
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Ratio of Cmax,ss/AUCss
Time Frame: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Trough concentrations of BIBV 308 SE before doses
Time Frame: up to day 4
|
up to day 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 1998
Primary Completion (Actual)
July 1, 1998
Study Registration Dates
First Submitted
August 21, 2014
First Submitted That Met QC Criteria
August 21, 2014
First Posted (Estimate)
August 22, 2014
Study Record Updates
Last Update Posted (Estimate)
August 22, 2014
Last Update Submitted That Met QC Criteria
August 21, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 528.22
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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