Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: BIBR 1048 MS - low dose (Drug); BIBR 1048 MS - high dose (Drug); BIBR 1048 MS + Pantoprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters
in healthy volunteer subjects.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Urinary excretion of total BIBR 953 ZWPeak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
Secondary outcome: Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZWTotal clearance (CLtot /f ) of BIBR 953 ZW after oral administration Occurence of adverse events Change from Baseline in pulse rate Change from Baseline in systolic and diastolic blood pressure Change from Baseline in clinical laboratory tests Changes from baseline in activated partial thromboplastin time (aPTT) Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR)) Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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 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)
- 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 familiar bleeding disorder
- Thrombocytes < 150000/µl
Locations and Contacts
Additional Information
Starting date: November 1999
Last updated: June 20, 2014
|