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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 1048 MS capsule formulation A; Drug: Pantoprazole; Drug: BIBR 1048 MS capsule formulation B; Drug: BIBR 1048 MS powder plus solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170805

1160.17

Details and patient eligibility

About

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.

Enrollment: 24 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Substudy 1

Experimental group

Description:

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

Treatment:

Drug: BIBR 1048 MS capsule formulation A

Drug: BIBR 1048 MS powder plus solution

Drug: Pantoprazole

Substudy 2

Experimental group

Description:

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

Treatment:

Drug: BIBR 1048 MS capsule formulation B

Drug: BIBR 1048 MS powder plus solution

Drug: Pantoprazole