Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS; Drug: Ranitidine

• Registration Number: NCT02170792
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2001-03
• 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: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIBR 1048 MS without ranitidine	BIBR 1048 MS	Low, medium or high dose
BIBR 1048 MS with ranitidine	BIBR 1048 MS	Low, medium or high dose in combination with ranitidine
BIBR 1048 MS with ranitidine	Ranitidine	Low, medium or high dose in combination with ranitidine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 blood pressure (systolic and diastolic)	baseline up to 36 h after last administration
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
Number of participants with adverse events	up to 36 h after last administration
Changes in activated prothrombin time (aPTT)	before and 2 hours after treatment
Changes from baseline in Pulse rate	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
Changes in international normalized ratio (INR )	before and 2 hours after treatment