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 An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration.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.
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.
Blood Pressure: Systolic 100-130 mmHg, Diastolic 70-90 mmHg.
Pulse Rate: 60-100 beats per minute (bpm).
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.
Single group
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Biological/VaccineEnoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt.
Primary Endpoints
Anti-Xa max: The maximum observed anti-Factor Xa activity in plasma following a single dose
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).
Secondary outcome
AUEC0-inf (Area under the Effect Curve extrapolated to infinity): The total area under the anti-Xa effect-time curve, extrapolated to infinity
Secondary outcome 2
Tmax (Time to maximum effect): The time post-dose at which the maximum anti-Xa activity occurs.
Secondary outcome 3
T½ (Half-life of anti-Xa activity): The time required for the anti-Xa activity to decline by 50% during the terminal phase.
Secondary outcome 4
λz (lambda z): The elimination rate constant of the anti-Xa activity. It is a pharmacokinetic parameter describing the rate at which the anti-Xa activity decreases in the plasma over time. It represents the slope of the terminal phase on a concentration-vs-time curve (logarithmic scale).
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