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

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

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