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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 ZW

Peak (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 953ZW

Total 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

Page last updated: August 23, 2015

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