Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

Inclusion criteria

• Healthy male volunteers without any clinical significant findings and complications
• Age: 20 - 45 years
• BMI: 18.5 - 25.0 kg/m2
• Signed informed consent

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
• Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
• History of jaundice
• Surgery of the gastrointestinal tract (except appendectomy).
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections.
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
• Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial.
• Participation in another trial with an investigational drug within two months prior to administration or during the trial.
• Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
• Inability to refrain from smoking during the trial.
• Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
• Drug abuse.
• Blood donation (more than 100 mL within four weeks prior to administration).
• Excessive physical activities (within one week prior to administration).
• Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
• Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).