Clinical trial NCT02265666: Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
Official title: Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-16
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 24 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 24 hours after drug administration
Secondary outcomes:
measure: 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)
timeFrame: up to 24 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 24 hours after drug administration
measure: Terminal rate constant in plasma
timeFrame: up to 24 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 24 hours after drug administration
measure: MRTtot (total mean residence time)
timeFrame: up to 24 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
timeFrame: up to 24 hours after drug administration
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
Other outcomes:
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