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

Launched by BOEHRINGER INGELHEIM · Oct 23, 2014

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Eligibility criteria

• 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