Healthy Participants StudyPhase 1NCT07517289
Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That From Clexane
A Phase 1 study testing Enoxaparin 40 Mg/0.4 mL Injectable Solution in people with Healthy Participants Study and The Focus of the Study is to Determine the Comparative Pharmacodynamic of Enoxaparin Sodium With That of Clexane in Healthy Human Participants, run by Egyptian International Pharmaceutical Industries Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Enoxaparin 40 Mg/0.4 mL Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: Study Name: (SPRING) Study of Pharmacodynamics and Relative Bioavailability of an Invented National Generic Enoxaparin
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
Read more
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.
Read the detailed description
This is an Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar with that from the Reference IMP, Clexane, Following Single-Dose Administration in Healthy Participants.
The data that will be collected include:
- Participant identification data
- Demographic data
- Smoking habits, caffeine use, medication use, alcohol consumption.
- Details of prior participation in any clinical or bioequivalence study.
- Participant medical history, physical examination
- Vital signs, laboratory results, ECG examination, drug abuse \& alcohol test
- Study Drug Information: Details of the administered drug, including time of administration.
- Concomitant Medications
- Blood sampling intervals for Pharmacodynamic (PD) analysis.
- Safety Monitoring: Documentation of any adverse events (AEs) Sample Collection and Sample Processing An intravenous cannula will be inserted before the pre-dose sample and will remain until 24 hours post-dose. Blood samples will be collected through an indwelling cannula placed in a forearm vein using a disposable syringe. If difficulty occurs in blood withdrawing or Participants not feeling comfortable with cannula, cannula will be removed, and remaining blood samples will be collected through fresh vein puncture or by re-cannulation. 5 ml of blood samples will be withdrawn and transferred into sodium citrate collection tubes at each time interval. After collection of blood samples placed in a wet ice container equivalent to the approximate height of the blood in the tube till centrifugation, then after centrifugation, transferred into an ice box containing wet ice and stored at -70°±15° immediately. After the collection of blood samples from all Participants at each time interval, samples will be centrifuged at 3500 RPM for 10 minutes.
All plasma samples will be transferred into pre-labeled (Study code, Participant No., Period, Sampling time point) polypropylene tubes. The polypropylene tubes will be transferred to freezer area in an icebox containing wet ice, and the polypropylene tubes will be stored at -70°±15° freezers. Total Number of Blood Samples: 19 samples in each study period. Volume of each sample: 5 ml. Sampling Hours: pre-dose and 0.5, 1.0, 1.5 (1 h 30 min), 2.0, 2.333 (2 h 20 min), 2.667 (2 h 40 min), 3.0, 3.333 (3 h 20 min), 3.667 (3 h 40 min), 4.0, 4.5 (4 h 30 min), 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h after dose administration Statistical analysis of primary endpoints for the two periods will include descriptive Statistics, ANOVA, and Confidence Interval (C.I.) of enoxaparin. The equivalence of the products will be concluded if the two -one -sided T-test 90 % confidence interval for the test to reference ratio means is within 80.00 - 125.00 % for each of the ln-transformed data of the following primary endpoints: For Anti-Factor Xa: Anti-Xa Amax, and Anti-Xa AUEC0-t , \& For Anti-Factor IIa: Anti-IIa Amax and Anti IIa AUE0-t and finally if there were no safety concerns and both products were well tolerated by the study Participants.
- 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
- Being tested
- Enoxaparin 40 Mg/0.4 mL Injectable Solution
- Keywords
- Enoxaparin Sodium, Pharmacodynamics, Clexane, Randomized, Healthy participants, single dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 40 Mg/0.4 mL Injectable SolutionBiological
Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Enoxaparin 40 Mg/0.4 mL Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
Anti-Xa max: The maximum observed anti-Factor Xa activity in plasma following a single dose
Measured: 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).
Measured: 4 months
Secondary outcomes (4)
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
Measured: 3 months
Secondary outcome 2
Tmax (Time to maximum effect): The time post-dose at which the maximum anti-Xa activity occurs.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian International Pharmaceutical Industries Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517289
- Sponsor's protocol ID
- SPRING Protocol V02
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Name: (SPRING) Study of Pharmacodynamics and Relative Bioavailability of an Invented National Generic Enoxaparin
- ClinicalTrials.gov ID
- NCT07517289
- Acronym / sponsor ID
- SPRING Protocol V02
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Egyptian International Pharmaceutical Industries CoIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar with that from the Reference IMP, Clexane, Following Single-Dose Administration in Healthy Participants.
The data that will be collected include:
- Participant identification data
- Demographic data
- Smoking habits, caffeine use, medication use, alcohol consumption.
- Details of prior participation in any clinical or bioequivalence study.
- Participant medical history, physical examination
- Vital signs, laboratory results, ECG examination, drug abuse \& alcohol test
- Study Drug Information: Details of the administered drug, including time of administration.
- Concomitant Medications
- Blood sampling intervals for Pharmacodynamic (PD) analysis.
- Safety Monitoring: Documentation of any adverse events (AEs) Sample Collection and Sample Processing An intravenous cannula will be inserted before the pre-dose sample and will remain until 24 hours post-dose. Blood samples will be collected through an indwelling cannula placed in a forearm vein using a disposable syringe. If difficulty occurs in blood withdrawing or Participants not feeling comfortable with cannula, cannula will be removed, and remaining blood samples will be collected through fresh vein puncture or by re-cannulation. 5 ml of blood samples will be withdrawn and transferred into sodium citrate collection tubes at each time interval. After collection of blood samples placed in a wet ice container equivalent to the approximate height of the blood in the tube till centrifugation, then after centrifugation, transferred into an ice box containing wet ice and stored at -70°±15° immediately. After the collection of blood samples from all Participants at each time interval, samples will be centrifuged at 3500 RPM for 10 minutes.
All plasma samples will be transferred into pre-labeled (Study code, Participant No., Period, Sampling time point) polypropylene tubes. The polypropylene tubes will be transferred to freezer area in an icebox containing wet ice, and the polypropylene tubes will be stored at -70°±15° freezers. Total Number of Blood Samples: 19 samples in each study period. Volume of each sample: 5 ml. Sampling Hours: pre-dose and 0.5, 1.0, 1.5 (1 h 30 min), 2.0, 2.333 (2 h 20 min), 2.667 (2 h 40 min), 3.0, 3.333 (3 h 20 min), 3.667 (3 h 40 min), 4.0, 4.5 (4 h 30 min), 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h after dose administration Statistical analysis of primary endpoints for the two periods will include descriptive Statistics, ANOVA, and Confidence Interval (C.I.) of enoxaparin. The equivalence of the products will be concluded if the two -one -sided T-test 90 % confidence interval for the test to reference ratio means is within 80.00 - 125.00 % for each of the ln-transformed data of the following primary endpoints: For Anti-Factor Xa: Anti-Xa Amax, and Anti-Xa AUEC0-t , \& For Anti-Factor IIa: Anti-IIa Amax and Anti IIa AUE0-t and finally if there were no safety concerns and both products were well tolerated by the study Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| helathy volunteers | Active comparator | Biological: Enoxaparin 40 Mg/0.4 mL Injectable SolutionA 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin 40 Mg/0.4 mL Injectable SolutionEnoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt. | Biological | helathy volunteers |
Primary outcome
Primary Endpoints
Time frame: 4 months
Anti-Xa max: The maximum observed anti-Factor Xa activity in plasma following a single dose
Primary outcome 2
Time frame: 4 months
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 secondary outcomes
Secondary outcome
Time frame: 3 months
Secondary outcome 2
Time frame: 3 months
Secondary outcome 3
Time frame: 3 months
Secondary outcome 4
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enoxaparin 40 Mg/0.4 mL Injectable Solution in people with Healthy Participants Study and The Focus of the Study is to Determine the Comparative Pharmacodynamic of Enoxaparin Sodium With That of Clexane in Healthy Human Participants, run by Egyptian International Pharmaceutical Industries Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoints (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.