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

Randomised 3-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Tablet C and Tablet D in Comparison to WIF Tablet in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIIL 284 BS tablet C; Drug: BIIL 284 BS tablet D; Drug: BIIL 284 BS WIF tablet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIL 284 BS tablet C	Drug: BIIL 284 BS tablet C
Experimental: BIIL 284 BS tablet D	Drug: BIIL 284 BS tablet D
Active Comparator: BIIL 284 BS WIF tablet	Drug: BIIL 284 BS WIF tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
tmax (Time from dosing to the maximum concentration of the analyte in plasma)	up to 72 hours after drug administration
MRTtot (Total mean residence time)	up to 72 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		up to 8 days after last drug administration
Number of subjects with clinically findings in vital functions	blood pressure, pulse rate, ECG	up to 8 days after last drug administration
Number of subjects with clinically findings in laboratory tests		up to 8 days after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Primary Completion (Actual): December 1, 1999

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 543.3