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Completed

NCT Number: NCT02265666

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

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

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIL 284 BS Tablet FF

Drug

BIIL 284 BS tablet C

Drug

standard breakfast

Other

Primary outcomes

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

    Time frame: up to 24 hours after drug administration

  2. Cmax (Maximum measured concentration of the analyte in plasma)

    Time frame: up to 24 hours after drug administration

Secondary outcomes

  1. 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)

    Time frame: up to 24 hours after drug administration

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

    Time frame: up to 24 hours after drug administration

  3. Terminal rate constant in plasma

    Time frame: up to 24 hours after drug administration

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

    Time frame: up to 24 hours after drug administration

  5. MRTtot (total mean residence time)

    Time frame: up to 24 hours after drug administration

  6. CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

    Time frame: up to 24 hours after drug administration

  7. Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

    Time frame: up to 24 hours after drug administration

  8. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  9. Number of subjects with clinically significant findings in vital functions

    Time frame: up to 8 days after last drug administration

    blood pressure, pulse rate, ECG

  10. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 8 days after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
First posted
Oct 16, 2014
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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