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

NCT ID: NCT02265653

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

BIIL 284 BS tablet C

Group Type: EXPERIMENTAL

BIIL 284 BS tablet C

Intervention Type: DRUG

BIIL 284 BS tablet D

Group Type: EXPERIMENTAL

BIIL 284 BS tablet D

Intervention Type: DRUG

BIIL 284 BS WIF tablet

Group Type: ACTIVE_COMPARATOR

BIIL 284 BS WIF tablet

Intervention Type: DRUG

Interventions

BIIL 284 BS tablet C

Intervention Type: DRUG

BIIL 284 BS tablet D

Intervention Type: DRUG

BIIL 284 BS WIF tablet

Intervention Type: DRUG

Eligibility Criteria

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)

• 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

543.3

Identifier Type: -

Identifier Source: org_study_id