Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food

Study Overview
=================
Brief Summary
-----------------
Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food

Official Title
-----------------
Relative Bioavailability of 200 mg Film Coated Tablets of BIBR 1048 MS With or Without Food Compared to 200 mg Solution of BIBR 1048 MS Given as Single Oral Administrations to Healthy Subjects. A 3-way Crossover, Open, Partly Randomized Study.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BIBR 1048 MS tablet
* Drug: BIBR 1048 MS solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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 ≤ + 20% Exclusion Criteria: Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders History of orthostatic hypotension, fainting spells and blackouts Diseases of the 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 trial Participation in another trial with an investigational drug within 2 months 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>BIBR 1048 MS tablet (fasted) - BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet after high fat meal | Drug: BIBR 1048 MS tablet<br> <br> Drug: BIBR 1048 MS solution<br> <br> |
| Experimental: Sequence 2<br>BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet (fasted) - BIBR 1048 MS tablet after high fat meal | Drug: BIBR 1048 MS tablet<br> <br> Drug: BIBR 1048 MS solution<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Maximum plasma concentration (Cmax) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Time from dosing to the maximum concentration (tmax) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activated partial thromboplastin time (aPTT) |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Change in international normalized ratio (INR) |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Terminal half-life (t1/2 ) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Total mean residence time (MRTtot) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Total clearance (CL/f) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug | 
| Volume of distribution (Vz/F) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug |