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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Asasantin®

Drug: Acetylsalicylic acid low dose

Drug: Acetylsalicylic acid high dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02268773

9.130

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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