Healthy
Conditions
Brief summary
Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as determined by results of screening * Signed informed consent in accordance with Good Clinical Practice (GCP) and local legislation * Age \>= 18 and \<= 55 years * Broca \>= - 20% and \<= + 20%
Exclusion criteria
* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder * Surgery of the gastro-intestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Chronic or relevant acute infections * History or hypersensitivity to Asasantin ER 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 result of the trial (\<= 10 days prior to administration or during the trial) * Participation in another trial with an investigational drug (\<= 1 month prior to administration or during the trial) * Known alcohol abuse * Known drug abuse * Blood donation ( \<=1 month prior to administration or during the trial) * Excessive physical activities (\<=5 days prior to administration or during the trial) * History of hemorrhagic diseases * History of gastro-intestinal ulcer, perforation or bleeding * History of bronchial asthma * Any laboratory value outside the reference range of clinical relevance For female subjects: * Pregnancy * Positive pregnant test * No adequate contraception (adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives) * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve at steady state (AUCss) | Up to 144 hours after drug administration |
| Percentage peak trough fluctuation (%PTF) | Up to 144 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole | Up to 144 hours after drug administration |
| Fluctuation of AUC (AUCfluct) of dipyridamole | Up to 144 hours after drug administration |
| Terminal half-life in the analyte (t1/2) of dipyridamole | Up to 144 hours after drug administration |
| Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp) | Up to 144 hours after drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to day 7 after last drug administration |
| Number of participants with Adverse Events | Up to day 7 after last drug administration |
| Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA) | Up to 106 hours after drug administration |
| Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole | Up to 144 hours after drug administration |
Outcome results
None listed