Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way Crossover, Randomised, Open Trial
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedJune 23, 2014
June 1, 2014
2 months
June 20, 2014
June 20, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Urinary excretion of total BIBR 953 ZW
Day 1, day 2, day 3 (different time points)
Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW
Day 1, day 2, day 3 (different time points)
Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW
Day 1, day 2, day 3 (different time points)
Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
Day 1, day 2, day 3 (different time points)
Secondary Outcomes (9)
Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW
Day 1, day 2, day 3 (different time points)
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
Day 1, day 2, day 3 (different time points)
Occurence of adverse events
6 weeks
Change from Baseline in pulse rate
Baseline, day 1,day 2, day 3, day 4
Change from Baseline in systolic and diastolic blood pressure
Baseline, day 1,day 2, day 3, day 4
- +4 more secondary outcomes
Study Arms (2)
BIBR 1048 MS
EXPERIMENTALBIBR 1048 MS + Pantoprazole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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
- History of any bleeding disorder including prolonged or habitual bleeding
- History of other hematologic disease
- History of cerebral bleeding (e.g. after a car accident)
- History of commotio cerebri
- Intake of drugs with a long-life (\> 24 hours) within 1 month prior to administration
- Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with investigational drug within 2 months prior to administration or during the trial
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol abuse (\> 60g/day)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2014
First Posted
June 23, 2014
Study Start
November 1, 1999
Primary Completion
January 1, 2000
Last Updated
June 23, 2014
Record last verified: 2014-06