Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects

NCT ID: NCT02170740

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

Brief Summary

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.

Conditions

Healthy

Study Design

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

Study Groups

BIBR 1048 MS

Group Type: EXPERIMENTAL

BIBR 1048 MS - low dose

Intervention Type: DRUG

BIBR 1048 MS - high dose

Intervention Type: DRUG

BIBR 1048 MS + Pantoprazole

Group Type: EXPERIMENTAL

BIBR 1048 MS - high dose

Intervention Type: DRUG

BIBR 1048 MS + Pantoprazole

Intervention Type: DRUG

Interventions

BIBR 1048 MS - low dose

Intervention Type: DRUG

BIBR 1048 MS - high dose

Intervention Type: DRUG

BIBR 1048 MS + Pantoprazole

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

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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
• History of any bleeding disorder including prolonged or habitual bleeding
• History of other hematologic disease
• History of cerebral bleeding (e.g. after a car accident)
• History of commotio cerebri
• Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
• Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with investigational drug within 2 months prior to administration or during the trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60g/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 familiar bleeding disorder
• Thrombocytes < 150000/µl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.14

Identifier Type: -

Identifier Source: org_study_id