Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects

Study Overview
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Brief Summary
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Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets

Official Title
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Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) 200/25 mg Capsules Bid and in a Combination of Persantin Immediate Release Tablets (100 mg Qid) and ASA Tablets (25 mg Bid) in an Open, Randomized, 2-way Crossover Study in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Asasantin (ER)
* Drug: Persantin
* Drug: Acetyl salicylic acid (ASA)


Participation Criteria
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Eligibility Criteria
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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

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)<br> | Drug: Asasantin (ER)<br> <br> |
| Active Comparator: Combination of Persantin and ASA<br> | Drug: Persantin<br> <br> Drug: Acetyl salicylic acid (ASA)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp) |  | Up to 144 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 | 
| 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 | 
| Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA) |  | Up to 106 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 |