Bioavailability of BIBR 953 ZW in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 1048 high; Drug: BIBR 1048 medium; Drug: BIBR 1048 low1; Drug: BIBR 1048 low2; Drug: Pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170766

1160.15

Details and patient eligibility

About

To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 ≤ + 20%

Exclusion criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• History of 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

BIBR 1048 low1

Experimental group

Description:

Two treatments of one single dose of BIBR 1048 12.5 mg without or with Pantoprazole 1. BIBR 1048 12.5 mg without Pantoprazole 2. BIBR 1048 12.5 mg with 40 mg Pantoprazole (bid)

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 low1

BIBR 1048 low2

Experimental group

Description:

Two treatments of one single dose of BIBR 1048 25 mg without or with Pantoprazole 1. BIBR 1048 25 mg without Pantoprazole 2. BIBR 1048 25 mg with 40 mg Pantoprazole (bid)

Treatment:

Drug: BIBR 1048 low2

Drug: Pantoprazole

BIBR 1048 medium

Experimental group

Description:

Two treatments of one single dose of BIBR 1048 50 mg without or with Pantoprazole 1. BIBR 1048 50 mg without Pantoprazole 2. BIBR 1048 50 mg with 40 mg Pantoprazole (bid)

Treatment:

Drug: BIBR 1048 medium

Drug: Pantoprazole

BIBR 1048 high

Experimental group

Description:

Two treatments of one single dose of BIBR 1048 100 mg without or with Pantoprazole 1. BIBR 1048 100 mg without Pantoprazole 2. BIBR 1048 100 mg with 40 mg Pantoprazole (bid)

Treatment:

Drug: BIBR 1048 high

Drug: Pantoprazole