Clinical trial NCT02170922: Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food


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

Primary outcomes:
measure: Area under the curve (AUC) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Maximum plasma concentration (Cmax) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Time from dosing to the maximum concentration (tmax) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
Secondary outcomes:
measure: Change in activated partial thromboplastin time (aPTT)
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Change in international normalized ratio (INR)
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Terminal half-life (t1/2 ) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Total mean residence time (MRTtot) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Total clearance (CL/f) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
measure: Volume of distribution (Vz/F) of BIBR 953 ZW
timeFrame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
Other outcomes:
Locations:
Study officials:
References: