Clinical trial NCT02170792: Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 30
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: 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.


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 \<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

Primary outcomes:
measure: Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
timeFrame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
measure: Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)
timeFrame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Secondary outcomes:
measure: Maximum concentration of drug in plasma ( Cmax )
timeFrame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
timeFrame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
measure: Changes from baseline in Pulse rate
timeFrame: baseline up to 36 h after last administration
measure: Changes from baseline in blood pressure (systolic and diastolic)
timeFrame: baseline up to 36 h after last administration
measure: Changes from baseline in ECG
timeFrame: baseline up to 36 h after last administration
measure: Changes from baseline in routine laboratory
timeFrame: baseline up to 36 h after last administration
measure: Number of participants with adverse events
timeFrame: up to 36 h after last administration
measure: Changes in international normalized ratio (INR )
timeFrame: before and 2 hours after treatment
measure: Changes in activated prothrombin time (aPTT)
timeFrame: before and 2 hours after treatment
Other outcomes:
Locations:
Study officials:
References: