Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects

Study Overview
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Brief Summary
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Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a 150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without food.

Official Title
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Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as HPMC Capsule Relative to a Gelatine Capsule, and Bioavailability of the HPMC Capsule Under the Influence of Food in Healthy Subjects. A Three-way Crossover, Randomised, Open Trial

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBR 1048 MS HPMC capsule
* Drug: BIBR 1048 MS gelatine capsule


Participation Criteria
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Eligibility Criteria
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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 ≤ 55 years BMI ≥ 18.5 and ≤ 29.9 kg/m2 Exclusion Criteria: Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders History of relevant 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 that might influence the results of the trial within 10 days prior to administration or during the 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
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIBR 1018 MS HPMC capsule fasted<br> | Drug: BIBR 1048 MS HPMC capsule<br> <br> |
| Experimental: BIBR 1048 MS HPMC capsule after high fat meal<br> | Drug: BIBR 1048 MS HPMC capsule<br> <br> |
| Active Comparator: BIBR 1048 MS gelatine capsule fasted<br> | Drug: BIBR 1048 MS gelatine capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ (area under the plasma concentration time curve from zero time extrapolated to infinity) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| AUC0-tz (The area under the plasma concentration time curve from zero time to the time of the last quantifiable concentration) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| Cmax (maximum measured concentration) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t½ (terminal half-life) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| MRT (Total mean residence time) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| CL/F (Total apparent clearance) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | 
| Vz/F (Apparent volume of distribution) of BIBR 953 ZW |  | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug |