Bioavailability of BIBR 953 ZW After 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 K; Drug: BIBR 1048 MS Capsule I; Drug: BIBR 1048 MS drinking solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170623

1160.33

Details and patient eligibility

About

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

Enrollment: 12 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
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion criteria

• Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating 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
  • 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 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 (> 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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12 participants in 2 patient groups

Period 1: BIBR 1048 MS with Pantoprazole

Experimental group

Description:

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) with 40 mg Pantoprazole (bid). Randomised sequence. 1. BIBR 1048 MS Capsule I with pantoprazole (bid for 3 days); 2. BIBR 1048 MS Capsule K with pantoprazole (bid for 3 days); 3. BIBR 1048 MS Drinking solution with Pantoprazole (bid for 3 days)

Treatment:

Drug: Pantoprazole

Drug: BIBR 1048 MS Capsule K

Drug: BIBR 1048 MS Capsule I

Drug: BIBR 1048 MS drinking solution

Period 2: BIBR 1048 MS

Experimental group

Description:

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) without Pantoprazole. Fixed sequence. 1. BIBR 1048 MS Capsule K (bid for 3 days); 2. BIBR 1048 MS Drinking solution (bid for 3 days)

Treatment:

Drug: BIBR 1048 MS Capsule K

Drug: BIBR 1048 MS drinking solution