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

NCT02265666 | Completed Phase 1

• 1 other identifier: 543.31
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 24 hours after drug administration

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 24 hours after drug administration

Secondary Outcomes (10)

• AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 24 hours after drug administration

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 24 hours after drug administration

• Terminal rate constant in plasma

  up to 24 hours after drug administration

• t½ (Terminal half-life of the analyte in plasma)

  up to 24 hours after drug administration

• MRTtot (total mean residence time)

  up to 24 hours after drug administration

Study Arms (2)

BIIL 284 BS Tablet FF

EXPERIMENTAL

Drug: BIIL 284 BS Tablet FF; Other: standard breakfast

BIIL 284 BS tablet C

ACTIVE COMPARATOR

Drug: BIIL 284 BS tablet C; Other: standard breakfast

Interventions

BIIL 284 BS Tablet FF DRUG

BIIL 284 BS Tablet FF

BIIL 284 BS tablet C DRUG

BIIL 284 BS tablet C

standard breakfast OTHER

BIIL 284 BS Tablet FF; BIIL 284 BS tablet C

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: October 15, 2014
• First Posted: October 16, 2014
• Study Start: October 1, 2001
• Primary Completion: November 1, 2001
• Last Updated: October 16, 2014

Record last verified: 2014-10