Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy 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 capsule formulation A (Drug); BIBR 1048 MS capsule formulation B (Drug); BIBR 1048 MS powder plus solution (Drug); Pantoprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule
formulation using melt extrusion technology was assessed in two separate, single dose, 3-way
crossover, open design, randomised studies. The 3-way crossover treatments included
administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A
or B and administration of the capsules with coadministration of pantoprazole.
Clinical Details
Official title: Bioavailability of BIBR 953 ZW After Single Oral Doses of Two Different 50 mg Capsules of BIBR 1048 MS With and Without Coadministration of Pantoprazole to Healthy Subjects Relative to Solution. Two Groups, 3-way Crossover, Randomised, Open Trial
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC0-∞ (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZWAUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW
Secondary outcome: Cmax (Maximum measured concentration) of BIBR 953 ZWtmax (Time from dosing to the maximum concentration) of BIBR 953 ZW t1/2 (Terminal half-life) of BIBR 953 ZW MRTtot (Total mean residence time) of BIBR 953 ZW CLtot/F (Total apparent clearance) of BIBR 953 ZW Vz/F (Apparent volume of distribution) of BIBR 953 ZW λz (terminal elimination rate constant) of BIBR 953 ZW Changes in aPTT (activated partial thromboplastin time) Changes in PT (prothrombin time)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 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 ≤ 55 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
Locations and Contacts
Additional Information
Starting date: April 2001
Last updated: June 20, 2014
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