New generic blood thinner put to the test in healthy volunteers
NCT ID NCT07517289
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks if a new generic version of the blood thinner enoxaparin works the same as the brand-name drug Clexane. About 26 healthy adults will receive a single dose of each drug, one week apart, and have their blood tested. The goal is to see if the generic is a safe and effective alternative.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy male and female participants aged 21 to 55 years at the time of the first dose administration. * Body Mass Index (BMI) between 18.5 and 30 kg/m², and body weight of at least 45 kg. * Participants must have vital signs within the normal range, as defined below, measured at pre-dose: * Blood Pressure: Systolic 100-130 mmHg, Diastolic 70-90 mmHg. * Pulse Rate: 60-100 beats per minute (bpm). * Body Temperature: 36.1-37.2 Exclusion Criteria: * Hypersensitivity to Enoxaparin or any of the formulation excipients * Contraindication to enoxaparin or related group of drugs, which includes but not limited to significant bleeding disorders, thrombocytopenia, blood-clothing disorders, and increased risk of bleeding. * History or presence of any medical condition or disease according to the opinion of the principal Investigator * History or presence of significant alcoholism or drug abuse in the past one year. * History or presence of heavy smoking (≥10 cigarettes or consumption of tobacco products and refusal to restrain from smoking or consumption of tobacco products for 48.00 hours before dosing until checkout of the study). * History or presence of significant renal, hepatobiliary, or liver impairment; a medical or familial history of seizures; significant asthma, urticaria, or other allergic reactions; or any other significant medical condition as determined by the Principal Investigator or their delegate. * History of difficulty with donating blood or difficulty in accessibility of veins * Use of any prescribed medication, OTC medicines or herbal medicines during the last two weeks preceding the first dosing * Participants who have any food allergy, intolerance, restriction, or special diet during the four weeks before screening * Participation in a drug research study within the past 2 months planned day of first dose administration * Donation of blood in the past 2 months before screening * Refusal to abstain from food (fasting) for at least ten hours before dosing * Refusal to abstain from alcohol or methylxanthine-containing beverages * Participants with a positive test for HBs-Ag, HIV-Ab, or HCV-Ab * Participant with a positive drug abuse test in urine at screening or at the time of check-in * Participant with abnormal baseline coagulation parameters, such as prolonged PT (if greater than 1.2 to 1.5 times the ULN of approximately 11 to 15 seconds), aPTT (if greater than 1.5 to 2.5 times the ULN of 25 to 40 seconds), or INR values (is above 1.4) outside the normal reference range. This is to minimize bleeding risk and confounding effects on study outcomes.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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