Evaluation of the effect of aspirin on platelet aggregation and coagulation parameters in healthy male volunteers

Completed

• Conditions: coagulation; platelet aggretion; 10064477

• Registration Number: NL-OMON34607
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

-Male subject of 18-55 years of age (inclusive);
-Have a Body Mass Index (BMI) between 18 and 32 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);

Exclusion Criteria

-Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit and/or at the start of the first study day (as judged by the investigator);
-Clinically relevant abnormal laboratory results, ECG and vital signs, or physical findings at screening and/or at the start of the first study day (as judged by the investigator);
-Positive test for hepatitis B, C or HIV ;
-Subjects with abnormal bleeding time at screening
-Subjects with history of gastrointestinal bleeding, recurrent nose bleeds, easy bruising;
-History of alcoholism or substance abuse within three years prior to screening
- history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
-Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>whole blood platelet aggregation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>-bleeding time, APPT, PT, ACT, TGT, factor Xa generation<br /><br>-Urinary TG, TAT, and creatinine</p><br>