Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose of Aspirin for Injection… (NCT07323680) | Clinical Trial Compass
CompletedPhase 1
Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Subjects
Czechia40 participantsStarted 2025-06-15
Plain-language summary
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy males and non-pregnant and no breast-feeding females, ≥ 18 and ≤ 55 years of age (on the day of Informed Consent).
. Non-smokers or past smokers (having ceased smoking at least 6 months before the first dosing).
. Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 on the day of screening.
. The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening.
. The subject has a hemoglobin level with the following acceptable range at Screening: (Male: 12.8 to 17.4 g/dL (128 to 174 g/L); Female: 10.8 to 15.0 g/dL (108 to 150 g/L).
. The subject has liver function tests within normal limits or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening.
. The subject has estimated glomerular filtration rate eGFR (CKD-EPI) ≥50 mL/min (0.833mL/sec/1.73m2) at Screening.
. Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum thromboxane B2 from baseline
Timeframe: 1 hour before dosing and 2, 5, 10, 20, 30, 45, 60, and 180 minutes post dosing]
. The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
. The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
. The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
. The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
. The subject has a history of hemorrhagic disorder.
. Prothrombin time or activated partial thromboplastin time level outside the normal range at screening and check-in.
. The subject has an increased risk of bleeding including but not limited to: any history of a clinically significant bleeding problem, any recent (within 30 days preceding the first dose of study drug) major trauma, platelet count \<100,000 mm3
. The subject has a history of glucose-6-phosphate dehydrogenase deficiency.