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

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)

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

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