Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects

NCT ID: NCT02170597

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31

Brief Summary

Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a 150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without food.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBR 1018 MS HPMC capsule fasted

Group Type: EXPERIMENTAL

BIBR 1048 MS HPMC capsule

Intervention Type: DRUG

BIBR 1048 MS HPMC capsule after high fat meal

Group Type: EXPERIMENTAL

BIBR 1048 MS HPMC capsule

Intervention Type: DRUG

BIBR 1048 MS gelatine capsule fasted

Group Type: ACTIVE_COMPARATOR

BIBR 1048 MS gelatine capsule

Intervention Type: DRUG

Interventions

BIBR 1048 MS HPMC capsule

Intervention Type: DRUG

BIBR 1048 MS gelatine capsule

Intervention Type: DRUG

Eligibility 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
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria

• Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of relevant 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 that might influence the results of the trial within 10 days prior to administration or during the 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.40

Identifier Type: -

Identifier Source: org_study_id