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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIIL 284 BS tablet D

Drug: BIIL 284 BS WIF tablet

Drug: BIIL 284 BS tablet C

Study type

Interventional

Funder types

Industry

Identifiers

NCT02265653

543.3

Details and patient eligibility

About

The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers

Enrollment

12 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 their 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

Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
Volunteers with history of orthostatic hypotension, fainting spells or blackouts
Volunteers with chronic or relevant acute infections
Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Volunteers who have taken 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
Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
Volunteers who participated in another study with an investigational drug within the last two months preceding this study
Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
Volunteers who drink more than 60g of alcohol per day
Volunteers who are dependent on drugs
Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Volunteers who have donated blood within the last 4 weeks (>= 100 mL)