Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That From Clexane

NCT07517289 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SPRING Protocol V02
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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 An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration.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

Conditions

Healthy Participants Study; The Focus of the Study is to Determine the Comparative Pharmacodynamic of Enoxaparin Sodium With That of Clexane in Healthy Human Participants

Keywords

Enoxaparin Sodium; Pharmacodynamics; Clexane; Randomized; Healthy participants; single dose

Outcome Measures

Primary Outcomes (2)

• Primary Endpoints

  Anti-Xa max: The maximum observed anti-Factor Xa activity in plasma following a single dose

  4 months

• Primary outcome 2

  AUEC0-t (Area under the Effect Curve from time zero to last quantifiable time): The area under the anti-Xa effect-time curve from time zero (dosing) to the last measurable time point (T).

  4 months

Secondary Outcomes (4)

• Secondary outcome

  3 months

• Secondary outcome 2

  3 months

• Secondary outcome 3

  3 months

• Secondary outcome 4

  3 months

Study Arms (1)

helathy volunteers

ACTIVE COMPARATOR

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. Test: Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml Reference: Clexane (Enoxaparin Sodium 40mg/0.4ml

Biological: Enoxaparin 40 Mg/0.4 mL Injectable Solution

Interventions

Enoxaparin 40 Mg/0.4 mL Injectable Solution BIOLOGICAL

Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt.

helathy volunteers

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Egyptian International Pharmaceutical Industries Co: lead

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 8, 2026
• Study Start: April 30, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03