Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects

Study Overview
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Brief Summary
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Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability

Official Title
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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).

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBV 308 SE solution
* Drug: BIBV 308 SE capsule 1
* Drug: BIBV 308 SE capsule 2


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 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

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 1<br> | Drug: BIBV 308 SE capsule 1<br> <br> |
| Experimental: BIBV 308 SE capsule 2<br> | Drug: BIBV 308 SE capsule 2<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 after drug administration | 
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) |  | up to 84 hours after drug administration | 
| Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss) |  | up to 84 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent peak-trough fluctuation (%PTF) |  | up to 84 hours after drug administration | 
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) |  | up to 84 hours after drug administration | 
| Mean residence time of the analyte in the body (MRTtot) |  | up to 84 hours after drug administration | 
| Apparent clearance of the analyte in plasma (CL/f) |  | up to 84 hours after drug administration | 
| Ratio of Cmax,ss/AUCss |  | up to 84 hours after drug administration | 
| Trough concentrations of BIBV 308 SE before doses |  | up to day 4 |