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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin; Aspirin, Dipyridamole Drug Combination; Dipyridamole; Salicylates; Salicylic Acid

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