Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy Subjects

NCT02170610 | Completed Phase 1

• 1 other identifier: 1160.34
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule formulation with and without coadministration of 40 mg Pantoprazole and to assess the effect of food on rate and extent of absorption.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• AUC0-∞ (area under curve of BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• AUC0-tf (area under the plasma concentration-time curve of BIBR 953 ZW over the time interval from 0 to the last quantifiable data point) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• Cmax (maximum concentration of drug in plasma) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

Secondary Outcomes (4)

• t½ (terminal elimination half life) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• MRTtot (mean time of residence of drug molecules in the body after oral dosing) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• CLtot/F (total clearance after oral administration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

• Vz/F (Apparent volume of distribution during the terminal phase) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug

Study Arms (3)

BIBR 1048 MS capsule

EXPERIMENTAL

Drug: BIBR 1048 MS

BIBR 1048 capsule with pantoprazole

EXPERIMENTAL

Drug: BIBR 1048 MS; Drug: Pantoprazole

BIBR 1048 capsule with food

EXPERIMENTAL

Drug: BIBR 1048 MS

Interventions

BIBR 1048 MS DRUG

BIBR 1048 MS capsule; BIBR 1048 capsule with food; BIBR 1048 capsule with pantoprazole

Pantoprazole DRUG

BIBR 1048 capsule with pantoprazole

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: March 1, 2002
• Primary Completion: May 1, 2002
• Last Updated: June 23, 2014

Record last verified: 2014-06