Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety

Inclusion Criteria:

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 50 years
• Broca >= -20% and <= +20%

Exclusion Criteria:

• Any finding 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 gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• 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 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
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
• Excessive physical activities (<= 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range or clinical relevance