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

NCT02170597 | Completed Phase 1

• 1 other identifier: 1160.40
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• AUC0-∞ (area under the plasma concentration time curve from zero time extrapolated to infinity) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• AUC0-tz (The area under the plasma concentration time curve from zero time to the time of the last quantifiable concentration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• Cmax (maximum measured concentration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

Secondary Outcomes (4)

• t½ (terminal half-life) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• MRT (Total mean residence time) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• CL/F (Total apparent clearance) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• Vz/F (Apparent volume of distribution) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

Study Arms (3)

BIBR 1018 MS HPMC capsule fasted

EXPERIMENTAL

Drug: BIBR 1048 MS HPMC capsule

BIBR 1048 MS HPMC capsule after high fat meal

EXPERIMENTAL

Drug: BIBR 1048 MS HPMC capsule

BIBR 1048 MS gelatine capsule fasted

ACTIVE COMPARATOR

Drug: BIBR 1048 MS gelatine capsule

Interventions

BIBR 1048 MS HPMC capsule DRUG

BIBR 1018 MS HPMC capsule fasted; BIBR 1048 MS HPMC capsule after high fat meal

BIBR 1048 MS gelatine capsule DRUG

BIBR 1048 MS gelatine capsule fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: August 1, 2003
• Primary Completion: September 1, 2003
• Last Updated: June 23, 2014

Record last verified: 2014-06