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

NCT02170623 | Completed Phase 1

• 1 other identifier: 1160.33
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Total amount of BIBR 953 ZW excreted into urine during one dosing interval (Ae0-12)

  Day 1 to day 10

• AUCss (Area under the plasma concentration-time curve at steady state) of BIBR 953 ZW

  0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

Secondary Outcomes (2)

• Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW

  0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

• tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW

  0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

Study Arms (2)

Period 1: BIBR 1048 MS with Pantoprazole

EXPERIMENTAL

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)

Drug: BIBR 1048 MS Capsule I; Drug: BIBR 1048 MS Capsule K; Drug: Pantoprazole; Drug: BIBR 1048 MS drinking solution

Period 2: BIBR 1048 MS

EXPERIMENTAL

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)

Drug: BIBR 1048 MS Capsule K; Drug: BIBR 1048 MS drinking solution

Interventions

BIBR 1048 MS Capsule I DRUG

25 mg BIBR 1048 MS

Period 1: BIBR 1048 MS with Pantoprazole

BIBR 1048 MS Capsule K DRUG

50 mg BIBR 1048 MS

Period 1: BIBR 1048 MS with Pantoprazole; Period 2: BIBR 1048 MS

Pantoprazole DRUG

40 mg pantoprazole

Period 1: BIBR 1048 MS with Pantoprazole

BIBR 1048 MS drinking solution DRUG

50 mg BIBR 1048 MS powder plus solution

Period 1: BIBR 1048 MS with Pantoprazole; Period 2: BIBR 1048 MS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: February 1, 2002
• Primary Completion: April 1, 2002
• Last Updated: June 23, 2014

Record last verified: 2014-06