Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pantoprazole; Drug: BIBR 1048 MS Capsule F; Drug: BIBR 1048 MS Drinking solution; Drug: BIBR 1048 MS Capsule E; Drug: BIBR 1048 MS Capsule G; Drug: BIBR 1048 MS Tablet H

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170636

1160.32

Details and patient eligibility

About

Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole

Enrollment: 15 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 ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion criteria

• Any finding 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 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 (> 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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15 participants in 2 patient groups

Period 1: BIBR 1048 MS + Pantoprazole

Experimental group

Description:

Five treatments with oral administration of 50 mg BIBR 1048 MS (bid for 3 days) and 40 mg Pantoprazole (bid). Randomised sequence. BIBR 1048 MS Capsule E with pantoprazole; BIBR 1048 MS Capsule F with pantoprazole; BIBR 1048 MS Capsule G with pantoprazole; BIBR 1048 MS Tablet H with pantoprazole; BIBR 1048 MS Drinking solution with pantoprazole

Treatment:

Drug: BIBR 1048 MS Tablet H

Drug: BIBR 1048 MS Capsule G

Drug: Pantoprazole

Drug: BIBR 1048 MS Capsule F

Drug: BIBR 1048 MS Drinking solution

Drug: BIBR 1048 MS Capsule E

Period 2: BIBR 1048 MS

Experimental group

Description:

Three treatments (fixed sequence) with oral administration of 50 mg BIBR 1048 MS (bid for 3 days). 1. BIBR 1048 MS Capsule E without pantoprazole; 2. BIBR 1048 MS Tablet H without pantoprazole; 3. BIBR 1048 MS Drinking solution without pantoprazole

Treatment:

Drug: BIBR 1048 MS Tablet H

Drug: BIBR 1048 MS Drinking solution

Drug: BIBR 1048 MS Capsule E