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

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

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 thromboxane B2 formation

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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