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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBX 245 CL - fed
* Drug: BIBX 245 CL- fasted


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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