Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Asasantin ER after a standardized breakfast	Asasantin ER	-
Asasantin ER after a standardized breakfast	Standardized breakfast	-
Asasantin ER at fasted state	Asasantin ER	-

Primary Outcome Measures

Name	Time	Method
Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)	up to 10 hours after drug administration
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss)	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 at steady state (Cmax,ss)	Up to 144 hours

Secondary Outcome Measures

Name	Time	Method
Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,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
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)	Up to 144 hours
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
Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde	up to day 19
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
Area under the concentration-time curve of ASA in plasma at steady state (AUCss)	Up to 144 hours
Maximum concentration of ASA in plasma at steady state (Cmax,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

Recruitment & Eligibility