Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIIL 284 BS Tablet FF

Other: standard breakfast

Drug: BIIL 284 BS tablet C

Study type

Interventional

Funder types

Industry

Identifiers

NCT02265666

543.31

Details and patient eligibility

About

The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers

Enrollment

16 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All participants are healthy males
Age range from 21 to 50 years
Broca-Index: within +- 20% of normal weight
In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

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 at least 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 trial with an investigational drug (<= two 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