Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.

Inclusion Criteria:

• healthy male subjects as determined by results of screening
• signed written informed consent in accordance with GCP and local legislation
• age >= 18 and <= 50 years
• Broca >= - 20% and <0 + 20%

Exclusion Criteria:

• any finding of the medical examination (including blood pressure, pulse rate and ECG)

• history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders

• history of orthostatic hypotension, fainting spells and blackouts

• diseases of central nervous system (such as epilepsy) or psychiatric disorders

• chronic or relevant acute infections

• History of:

  • allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • any bleeding disorder including prolonged or habitual bleeding
  • other hematologic disease
  • cerebral bleeding (e.g. after a car accident)
  • commotio cerebri

• intake of drugs with a long half-life (>24 hours) within 1 month prior to administration

• use of any drugs which might influence the results of the trial within 10 days prior to administration or during administration

• participation in another trial with an investigational drug within 2 month prior to administration or during trial

• smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

• alcohol abuse (>60 g / day)

• drug abuse

• blood donation within 1 month prior to administration or during the trial

• excessive physical activities within 5 days prior to administration or during the trial

• any laboratory value outside the clinically accepted reference range

• history of any familial bleeding disorder

• Thrombocytes < 150000 /µl