Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects

Study Overview
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Brief Summary
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Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.

Official Title
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Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of 50 mg BIBV 308 SE Each, Versus a Solution of 50 mg BIBV 308 SE Administered Orally Twice a Day for 3.5 Days to Healthy Subjects (Cross-over, Open, Randomized)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBV 308 SE solution
* Drug: BIBV 308 SE capsule L
* Drug: BIBV 308 SE capsule S


Participation Criteria
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Eligibility Criteria
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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 (including thyroid) disorders Surgery of the gastro-intestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders Chronic or acute relevant infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator 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 during the period of the study Known alcohol (> 60 g/day) or drug abuse Blood donation (<= 1 month prior to administration) Excessive physical activities (<= 5 days prior to administration) Any laboratory value outside the normal range of clinical relevance History of haemorrhagic diathesis History of gastro-intestinal ulcer, perforation or bleeding History of bronchial asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIBV 308 SE solution<br> | Drug: BIBV 308 SE solution<br> <br> |
| Experimental: BIBV 308 SE capsule L<br> | Drug: BIBV 308 SE capsule L<br> <br> |
| Experimental: BIBV 308 SE capsule S<br> | Drug: BIBV 308 SE capsule S<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma at steady state (AUCss) |  | up to 84 hours | 
| Maximum plasma concentration at steady state (Cmax,ss) |  | up to 84 hours | 
| Minimum plasma concentration at steady state (Cmin,ss) |  | up to 84 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent peak-to-trough fluctuation (%PTF) |  | up to 84 hours | 
| Time to maximum plasma concentration in steady state (tmax,ss) |  | up to 84 hours | 
| Mean residence time in steady state (MRT,ss) |  | up to 84 hours | 
| Total plasma clearance (CL/f) |  | up to 84 hours | 
| Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss) |  | up to 84 hours | 
| Number of patients with adverse events |  | up to 5 days after last drug administration | 
| Number of patients with clinically significant findings in vital signs | pulse rate, blood pressure | up to 5 days after last drug administration | 
| Number of patients with clinically significant findings in laboratory tests |  | up to 5 days after last drug administration | 
| Trough concentration of BIBV 308 SE before doses |  | up to 84 hours |