Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That Fro… (NCT07517289) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That From Clexane
26 participantsStarted 2026-04-30
Plain-language summary
An Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar 40mg/0.4ml with that from the Reference IMP, Clexane® (40 mg/0.4ml), Following Single-Dose Administration in Healthy Participants. Test: Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt. Reference: Clexane (Enoxaparin Sodium 40mg/0.4ml) manufactured by Sanofi Aventis, Egypt. Primary objective:
To assess biosimilarity between a single dose from the test product versus the reference product in healthy participants
Secondary objective:
To investigate the safety and tolerability of the formulations. This study is a randomized single-dose, two-way, two-period, two-sequence, crossover biosimilarity study with a washout period of one week after each dosing.A minimum of 21 healthy adult male and female participants from Egyptian population will be enrolled in this study, along with 5 additional participants to account for potential dropouts or withdrawal. 26 Participants plus 1-4 alternates will be admitted to the study. An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration. Withdrawals after study drug administration will not be replaced. All participants will be healthy adults aged (21-55) years, with a BMI within the accepted range of 18.5-30 kg/m², and will meet the study's selection criteria.
Who can participate
Age range
21 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 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…
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
Primary Endpoints
Timeframe: 4 months
2
Primary outcome 2
Timeframe: 4 months
Trial details
NCT IDNCT07517289
SponsorEgyptian International Pharmaceutical Industries Co