Healthy
Conditions
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 thromboxane B2 formation
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute serum thromboxane B2 level | At day 3 after start of drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in time course of inhibition of serum thromboxane B2 | Pre-dose, up to day 14 after start of drug administration | — |
| Change in time course of inhibition of platelet aggregation | Pre-dose, up to day 14 after start of drug administration | — |
| Changes from baseline in vital signs | Pre-dose, up to 14 days after first drug administration | systolic and diastolic blood pressure, pulse rate |
| Change in platelet aggregation | At day 3 after start of drug administration | measured ex-vivo |
| Changes from baseline in physical examination | Pre-dose, up to 14 days after first drug administration | — |
| Changes from baseline in 12-lead ECG | Pre-dose, up to 14 days after first drug administration | — |
| Number of patients with adverse events | Up to 14 days after start of drug administration | — |
| Changes from baseline in laboratory tests | Pre-dose, up to 14 days after first drug administration | — |
Outcome results
None listed