Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02273505
Start Date
April 1 2000
Last Update
October 24 2014
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