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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 ZW

AUC0-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 ZW

tmax (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

Page last updated: August 23, 2015

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