Healthy
Conditions
Brief summary
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE * Healthy subjects as determined by results of screening * Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation * Age \>= 18 and \<= 55 years * Broca \>= -20% and \<= +20 %
Exclusion criteria
* Poor individual absorption kinetics of BIBV 308 SE in previous studies * Any findings 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 the gastro-intestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * Chronic or relevant acute infections * Hypersensitivity to BIBV 308 SE and any of the excipients * 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 days 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 * Known alcohol or drug abuse * Blood donation \<= 1 month prior to administration * Excessive physical activities \<= 5 days prior to administration * History of hemorrhagic diathesis * History of gastro-intestinal ulcer, perforation or bleeding * History of bronchial asthma * Any laboratory value outside the reference range of clinical relevance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state (AUCss) | up to 84 hours after drug administration |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) | up to 84 hours after drug administration |
| Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss) | up to 84 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Apparent clearance of the analyte in plasma (CL/f) | up to 84 hours after drug administration |
| Percent peak-trough fluctuation (%PTF) | up to 84 hours after drug administration |
| Trough concentrations of BIBV 308 SE before doses | up to day 4 |
| Ratio of Cmax,ss/AUCss | up to 84 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to 84 hours after drug administration |
| Mean residence time of the analyte in the body (MRTtot) | up to 84 hours after drug administration |
Outcome results
None listed