Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food

NCT02170922 | Completed Phase 1

• 1 other identifier: 1160.3
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the curve (AUC) of BIBR 953 ZW

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

• Maximum plasma concentration (Cmax) of BIBR 953 ZW

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

• Time from dosing to the maximum concentration (tmax) of BIBR 953 ZW

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

Secondary Outcomes (6)

• Change in activated partial thromboplastin time (aPTT)

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

• Change in international normalized ratio (INR)

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

• Terminal half-life (t1/2 ) of BIBR 953 ZW

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

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

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

• Total clearance (CL/f) of BIBR 953 ZW

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

Study Arms (2)

Sequence 1

EXPERIMENTAL

BIBR 1048 MS tablet (fasted) - BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet after high fat meal

Drug: BIBR 1048 MS tablet; Drug: BIBR 1048 MS solution

Sequence 2

EXPERIMENTAL

BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet (fasted) - BIBR 1048 MS tablet after high fat meal

Drug: BIBR 1048 MS tablet; Drug: BIBR 1048 MS solution

Interventions

BIBR 1048 MS tablet DRUG

Sequence 1; Sequence 2

BIBR 1048 MS solution DRUG

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 50 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 ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%

You may not qualify if:

• 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

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: July 1, 1999
• Primary Completion: August 1, 1999
• Last Updated: June 23, 2014

Record last verified: 2014-06