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

Study Overview
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Brief Summary
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Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state

Official Title
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Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin Extended Release (ER) 200/25 mg Capsules b.i.d. in a Randomized, Open, 2-way Cross-over Study in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Asasantin ER
* Other: Standardized breakfast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asasantin ER after a standardized breakfast<br> | Drug: Asasantin ER<br> <br> Other: Standardized breakfast<br> <br> |
| Active Comparator: Asasantin ER at fasted state<br> | Drug: Asasantin ER<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Maximum concentration of ASA in plasma at steady state (Cmax,ss) |  | Up to 144 hours | 
| Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde |  | up to day 19 | 
| 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 |