Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

NCT ID: NCT02170805

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief Summary

The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of pantoprazole.

Conditions

Healthy

Study Design

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

Study Groups

Substudy 1

Three treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence

1. BIBR 1048 MS capsule formulation A without pantoprazole;

2. BIBR 1048 MS capsule formulation A with coadministration of 40 mg pantoprazole (bid);

3. BIBR 1048 MS powder plus solution without pantoprazole

Group Type: EXPERIMENTAL

BIBR 1048 MS capsule formulation A

Intervention Type: DRUG

BIBR 1048 MS, formulation A 50 mg

BIBR 1048 MS powder plus solution

Intervention Type: DRUG

BIBR 1048 MS, powder plus solution 50 mg

Pantoprazole

Intervention Type: DRUG

Pantoprazole 40 mg

Substudy 2

Three treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence

1. BIBR 1048 MS capsule formulation B without pantoprazole;

2. BIBR 1048 MS capsule formulation B with coadministration of 40 mg pantoprazole (bid);

3. BIBR 1048 MS powder plus solution without pantoprazole

Group Type: EXPERIMENTAL

BIBR 1048 MS capsule formulation B

Intervention Type: DRUG

BIBR 1048 MS, formulation B 50 mg

BIBR 1048 MS powder plus solution

Intervention Type: DRUG

BIBR 1048 MS, powder plus solution 50 mg

Pantoprazole

Intervention Type: DRUG

Pantoprazole 40 mg

Interventions

BIBR 1048 MS capsule formulation A

BIBR 1048 MS, formulation A 50 mg

Intervention Type: DRUG

BIBR 1048 MS capsule formulation B

BIBR 1048 MS, formulation B 50 mg

Intervention Type: DRUG

BIBR 1048 MS powder plus solution

BIBR 1048 MS, powder plus solution 50 mg

Intervention Type: DRUG

Pantoprazole

Pantoprazole 40 mg

Intervention Type: DRUG

Other Intervention Names

Pantozol®

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 ≤ 55 years
• Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria

• Any findings of the medical examination (including blood pressure, pulse rate and 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
• 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 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 (> 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: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.17

Identifier Type: -

Identifier Source: org_study_id