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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34607
Enrollment
6
Registered
2010-08-03
Start date
2010-09-14
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation platelet aggretion

Interventions

Administration of aspirin (6 days, 75 mg per day)

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary: whole blood platelet aggregation

Secondary

MeasureTime frame
Secondary: -bleeding time, APPT, PT, ACT, TGT, factor Xa generation -Urinary TG, TAT, and creatinine

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)