Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS Capsule D; Drug: BIBR 1048 MS tartaric acid solution; Drug: BIBR 1048 MS Capsule C; Drug: BIBR 1048 MS Capsule A; Drug: BIBR 1048 MS Capsule B; Drug: Pantoprazole

• Registration Number: NCT02170896
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2001-12
• 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: 16

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
• Age >= 18 and <= 55 years
• Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m²

Read More

Exclusion Criteria

• Any finding at the medical examination (including blood pressure, pulse rate and ECG (electrocardiogram)) deviation from normal and of clinical relevance
• History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of relevant 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 drug with a long half-life (> 24 hours) within 1 month prior to administration
• Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the 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 (> 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 familial bleeding disorder
• Thrombocytes < 150000/µl

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1: BIBR1048 MS Capsule D+Pantoprazole	BIBR 1048 MS Capsule D	-
Period 1: BIBR1048 MS solution+Pantoprazole	BIBR 1048 MS tartaric acid solution	-
Period 2: BIBR1048 MS Capsule C	BIBR 1048 MS Capsule C	-
Period 2: BIBR1048 MS Capsule D	BIBR 1048 MS Capsule D	-
Period 2: BIBR1048 MS solution	BIBR 1048 MS tartaric acid solution	-
Period 1: BIBR1048 MS Capsule A+Pantoprazole	BIBR 1048 MS Capsule A	-
Period 1: BIBR1048 MS Capsule B+Pantoprazole	BIBR 1048 MS Capsule B	-
Period 1: BIBR1048 MS Capsule C+Pantoprazole	BIBR 1048 MS Capsule C	-
Period 1: BIBR1048 MS Capsule A+Pantoprazole	Pantoprazole	-
Period 1: BIBR1048 MS Capsule B+Pantoprazole	Pantoprazole	-
Period 1: BIBR1048 MS Capsule C+Pantoprazole	Pantoprazole	-
Period 1: BIBR1048 MS Capsule D+Pantoprazole	Pantoprazole	-
Period 1: BIBR1048 MS solution+Pantoprazole	Pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals	up to 3 days after each administration
Area under the concentration time course at steady state (AUCss)	0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2

Secondary Outcome Measures

Name	Time	Method
Occurence of adverse events	up to 40 days
Maximum plasma concentration at steady state (Cmax,ss)	0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2
Time at which maximum plasma concentration occurs after dosing during steady state (tmax,ss)	0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2