Healthy
Conditions
Brief summary
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
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 (including thyroid) disorders * Surgery of the gastro-intestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * Chronic or acute relevant infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * 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 during the period of the study * Known alcohol (\> 60 g/day) or drug abuse * Blood donation (\<= 1 month prior to administration) * Excessive physical activities (\<= 5 days prior to administration) * Any laboratory value outside the normal range of clinical relevance * History of haemorrhagic diathesis * History of gastro-intestinal ulcer, perforation or bleeding * History of bronchial asthma
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 |
| Maximum plasma concentration at steady state (Cmax,ss) | up to 84 hours |
| Minimum plasma concentration at steady state (Cmin,ss) | up to 84 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total plasma clearance (CL/f) | up to 84 hours | — |
| Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss) | up to 84 hours | — |
| Number of patients with adverse events | up to 5 days after last drug administration | — |
| Percent peak-to-trough fluctuation (%PTF) | up to 84 hours | — |
| Number of patients with clinically significant findings in laboratory tests | up to 5 days after last drug administration | — |
| Trough concentration of BIBV 308 SE before doses | up to 84 hours | — |
| Number of patients with clinically significant findings in vital signs | up to 5 days after last drug administration | pulse rate, blood pressure |
| Time to maximum plasma concentration in steady state (tmax,ss) | up to 84 hours | — |
| Mean residence time in steady state (MRT,ss) | up to 84 hours | — |
Outcome results
None listed