Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BIIL 284 BS tablet CDrug: BIIL 284 BS boliOther: standard breakfast
- Registration Number
- NCT02265640
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of normal weight
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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 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 study with an investigational drug (>= tow 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIIL 284 BS tablet C - fasted BIIL 284 BS tablet C - BIIL 284 BS boli - fed BIIL 284 BS boli - BIIL 284 BS boli - fasted BIIL 284 BS boli - BIIL 284 BS boli - fed standard breakfast - BIIL 284 BS tablet C - fed standard breakfast - BIIL 284 BS tablet C - fed BIIL 284 BS tablet C -
- Primary Outcome Measures
Name Time Method Plasma levels of BIIL 315 ZW up to 72 hours after drug administration AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 72 hours after drug administration Cmax (Maximum measured concentration of the analyte in plasma) up to 72 hours after drug administration
- Secondary Outcome Measures
Name Time Method tmax (Time from dosing to the maximum concentration of the analyte in plasma) up to 72 hours after drug administration t½ (Terminal half-life of the analyte in plasma) up to 72 hours after drug administration MRTtot (Total mean residence time) up to 72 hours after drug administration Vz/F (Apparent volume of distribution of the analyte during the terminal phase) up to 72 hours after drug administration CLtot/F (Total clearance after oral administration) up to 72 hours after drug administration Number of subjects with adverse events up to 8 days after last drug administration Number of subjects with clinically significant findings in vital functions up to 8 days after last drug administration blood pressure, pulse rate, ECG
Number of subjects with clinically significant findings in laboratory tests up to 8 days after last drug administration