Healthy
Conditions
Brief summary
Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state
Interventions
DRUGAsasantin ER
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 written 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 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 * History of 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 results 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) * Excessive physical activities (\< 5 days prior to administration) * History of hemorrhagic diatheses * History of gastro-intestinal ulcer, perforating or bleeding * History of bronchial asthma * Any laboratory value outside the normal range of clinical relevance Female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (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 concentration-time curve of dipyridamole in plasma at steady state (AUCss) | Up to 144 hours |
| Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss) | Up to 144 hours |
| Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2) | up to day 19 |
| Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h) | up to 10 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration of ASA in plasma at steady state (Cmax,ss) | Up to 144 hours |
| Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss) | Up to 144 hours |
| Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h) | Up to 10 hours after start of drug administration |
| Percent peak trough fluctuation of dipyridamole in plasma (%PTF) | Up to 144 hours |
| Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss) | Up to 144 hours |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) | up to day 7 |
| Number of subjects with abnormal changes in laboratory parameters | Up to 144 hours |
| Number of subjects with adverse events | up to 2 months |
| Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde | up to day 19 |
| Terminal half-life of the analytes in plasma (t1/2) | Up to 144 hours |
| Percent area under the curve fluctuation of dipyridamole in plasma (AUCfluct) | Up to 144 hours |
| Area under the concentration-time curve of ASA in plasma at steady state (AUCss) | Up to 144 hours |
Outcome results
None listed