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

Study Overview
=================
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

Official Title
-----------------
A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Asasantin®
* Drug: Acetylsalicylic acid low dose
* Drug: Acetylsalicylic acid high dose


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetylsalicylic acid low dose with Asasantin®<br> | Drug: Asasantin®<br> <br> * Other names: modified-release dipyridamole;Drug: Acetylsalicylic acid low dose<br> <br> |
| Active Comparator: Acetylsalicylic acid high dose<br> | Drug: Acetylsalicylic acid high dose<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute serum thromboxane B2 level |  | At day 3 after start of drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet aggregation | measured ex-vivo | At day 3 after start of drug administration | 
| 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 | systolic and diastolic blood pressure, pulse rate | Pre-dose, up to 14 days after first drug administration | 
| Changes from baseline in laboratory tests |  | Pre-dose, up to 14 days after first drug administration | 
| 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 |