Status:
COMPLETED
Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of ...
Eligibility Criteria
Inclusion
- Male or female healthy volunteers aged 20 to 50 years
- Clinically normal medical history
- Clinically normal findings on physical examination
- Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
- Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)
Exclusion
- Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
- Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
- Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) \> 80 IU/L, bilirubin \> 34 µmol/L or creatinine \> 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
- Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
- Active peptic ulceration or history of peptic ulcer disease
- Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
- History of any bleeding disorders
- History of cerebral haemorrhage
- Resting, seated blood pressure less than 90/60 mmHg
- Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
- Any indication of current or previous abuse of alcohol, solvents or drugs
- Any chronic illness
- Asthma
- Requirement for any other medication one month before or during the study
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded
- Previous participation in the randomisation phase of this clinical trial
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02268773
Start Date
January 1 2000
Last Update
October 20 2014
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