Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIBX 245 CL - fed; Drug: BIBX 245 CL- fasted

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 50 years
• Broca >= -20% and <= +20%

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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 drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= 2 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 (> 60 g/day)
• Drug abuse
• Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
• Excessive physical activities (<= 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range or clinical relevance

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBX 245 CL - fed; after a light breakfast with 40 g fat	Drug: BIBX 245 CL - fed
Active Comparator: BIBX 245 CL - fasted	Drug: BIBX 245 CL- fasted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (Maximum measured concentration of the analyte in plasma)	up to 24 hours post dose
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 post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)	up to 24 hours post dose
λz (Terminal rate constant in plasma)	up to 24 hours post dose
t½ (Terminal half-life of the analyte in plasma)	up to 24 hours post dose
MRTtot (Mean residence time)	up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	up to 20 days
Assessment of tolerability by investigator	after 20 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 1998
• Primary Completion (Actual): June 1, 1998

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 537.7