Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

NCT ID: NCT02265640

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31

Brief Summary

The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIL 284 BS boli - fasted

Group Type: EXPERIMENTAL

BIIL 284 BS boli

Intervention Type: DRUG

BIIL 284 BS boli - fed

Group Type: EXPERIMENTAL

BIIL 284 BS boli

Intervention Type: DRUG

standard breakfast

Intervention Type: OTHER

BIIL 284 BS tablet C - fasted

Group Type: ACTIVE_COMPARATOR

BIIL 284 BS tablet C

Intervention Type: DRUG

BIIL 284 BS tablet C - fed

Group Type: ACTIVE_COMPARATOR

BIIL 284 BS tablet C

Intervention Type: DRUG

standard breakfast

Intervention Type: OTHER

Interventions

BIIL 284 BS boli

Intervention Type: DRUG

BIIL 284 BS tablet C

Intervention Type: DRUG

standard breakfast

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants are healthy males
• Age range from 21 to 50 years
• Broca-Index: within +- 20% of normal weight

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
• Use of any drugs which might influence the results of the trial (>= one week prior to administration or during the trial)
• Participation in another study with an investigational drug (>= tow months prior to administration or during the trial)
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60g/day)
• Drug abuse
• Blood donation (>= 100 mL) within four weeks prior to administration or during the trial
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

543.28

Identifier Type: -

Identifier Source: org_study_id