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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 1048 MS Capsule D; Drug: BIBR 1048 MS Capsule A; Drug: BIBR 1048 MS tartaric acid solution; Drug: Pantoprazole; Drug: BIBR 1048 MS Capsule B; Drug: BIBR 1048 MS Capsule C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170896

1160.31

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 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 (Good Clinical Practice) and local legislation
• Age >= 18 and <= 55 years
• Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m²

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 8 patient groups

Period 1: BIBR1048 MS Capsule A+Pantoprazole

Experimental group

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 MS Capsule A

Period 1: BIBR1048 MS Capsule B+Pantoprazole

Experimental group

Treatment:

Drug: BIBR 1048 MS Capsule B

Drug: Pantoprazole

Period 1: BIBR1048 MS Capsule C+Pantoprazole

Experimental group

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 MS Capsule C

Period 1: BIBR1048 MS Capsule D+Pantoprazole

Experimental group

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 MS Capsule D

Period 1: BIBR1048 MS solution+Pantoprazole

Active Comparator group

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 MS tartaric acid solution

Period 2: BIBR1048 MS Capsule C

Experimental group

Treatment:

Drug: BIBR 1048 MS Capsule C

Period 2: BIBR1048 MS Capsule D

Experimental group

Treatment:

Drug: BIBR 1048 MS Capsule D

Period 2: BIBR1048 MS solution

Active Comparator group

Treatment:

Drug: BIBR 1048 MS tartaric acid solution