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 An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration.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 range21 Years – 55 Years

SexALL

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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…

What they're measuring

Primary Endpoints

Timeframe: 4 months

Primary outcome 2

Timeframe: 4 months

Trial details

NCT IDNCT07517289

SponsorEgyptian International Pharmaceutical Industries Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06