Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIBR 1048 MS; Drug: Ranitidine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBR 1048 MS with ranitidine; Low, medium or high dose in combination with ranitidine	Drug: BIBR 1048 MS; Low, medium or high dose; Drug: Ranitidine; 150mg; Other Names: Zantic ®
Experimental: BIBR 1048 MS without ranitidine; Low, medium or high dose	Drug: BIBR 1048 MS; Low, medium or high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)	before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)	before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration of drug in plasma ( Cmax )	before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)	before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Changes from baseline in Pulse rate	baseline up to 36 h after last administration
Changes from baseline in blood pressure (systolic and diastolic)	baseline up to 36 h after last administration
Changes from baseline in ECG	baseline up to 36 h after last administration
Changes from baseline in routine laboratory	baseline up to 36 h after last administration
Number of participants with adverse events	up to 36 h after last administration
Changes in international normalized ratio (INR )	before and 2 hours after treatment
Changes in activated prothrombin time (aPTT)	before and 2 hours after treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): March 1, 2001

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Dabigatran; Ranitidine; Ranitidine bismuth citrate
• Other Study ID Numbers: 1160.16