Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

NCT ID: NCT02170792

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28

Brief Summary

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.

Conditions

Healthy

Study Design

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

Study Groups

BIBR 1048 MS with ranitidine

Low, medium or high dose in combination with ranitidine

Group Type: EXPERIMENTAL

BIBR 1048 MS

Intervention Type: DRUG

Low, medium or high dose

Ranitidine

Intervention Type: DRUG

150mg

BIBR 1048 MS without ranitidine

Low, medium or high dose

Group Type: EXPERIMENTAL

BIBR 1048 MS

Intervention Type: DRUG

Low, medium or high dose

Interventions

BIBR 1048 MS

Low, medium or high dose

Intervention Type: DRUG

Ranitidine

150mg

Intervention Type: DRUG

Other Intervention Names

Zantic ®

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 <0 + 20%

Exclusion Criteria

• any finding of the medical examination (including blood pressure, pulse rate and ECG)
• history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• history of orthostatic hypotension, fainting spells and blackouts
• diseases of 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 administration
• participation in another trial with an investigational drug within 2 month 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: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.16

Identifier Type: -

Identifier Source: org_study_id