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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS tablet; Drug: BIBR 1048 MS solution

• Registration Number: NCT02170922
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Primary Completion: 1999-08
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	BIBR 1048 MS tablet	BIBR 1048 MS tablet (fasted) - BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet after high fat meal
Sequence 1	BIBR 1048 MS solution	BIBR 1048 MS tablet (fasted) - BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet after high fat meal
Sequence 2	BIBR 1048 MS tablet	BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet (fasted) - BIBR 1048 MS tablet after high fat meal
Sequence 2	BIBR 1048 MS solution	BIBR 1048 MS solution (fasted) - BIBR 1048 MS tablet (fasted) - BIBR 1048 MS tablet after high fat meal

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Volume of distribution (Vz/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
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
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
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
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
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