HealthyPhase 1NCT05265676
Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects
A Phase 1 study testing Enoxaparin Sodium (Venus Remedies Limited) and Enoxaparin Sodium (Sanofi) in people with Healthy, run by Venus Remedies Limited at 1 site in India.
Trial summary
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited, India) and its innovator product (Clexane®… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Enoxaparin Sodium (Venus Remedies Limited) and Enoxaparin Sodium (Sanofi)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 26 Feb 2021to 11 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Volunteers must not be enrolled in the study if they meet any one of the following criteria:
- History of hypersensitivity or idiosyncratic reaction to Enoxaparin Sodium, pork, heparin or its derivatives, other low molecular weight heparins or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination (for female volunteers)].
- Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
Show all 32Show fewer
- A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see http://medicine.iupui.edu/clinpharm/ddis/main-table).
- History or evidence of drug dependence.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody and / or syphilis (RPR).
- Volunteers who have received a known investigational or equivalent to this drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- Intolerance to venipuncture
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- Institutionalized volunteers.
- Use of any prescribed medications within 14 days prior to the first dose of study medication.
- Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- History or presence of active major bleeding.
- History or presence of Thrombocytopenia.
- Volunteer having Platelet count lower than lower limit of normal range during screening.
- Volunteer having Prothrombin Time and Activated Partial Thromboplastin Time 1.1 times higher than the upper limit of normal range during screening.
- Volunteer having INR outside of normal range during screening.
- Presence of minor bleeding episodes such as epistaxis, rectal bleeding and gingival bleeding.
- Volunteers with history of stomach ulcer/duodenal ulcer/intestinal ulcers.
- Volunteers have undergone any surgery in recent past.
- Volunteers with the history of piles and fissure.
- Volunteer having any tattoo or any other type of scar at site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover, Balanced, Single Subcutaneous Dose Pharmacodynamic Comparative Equivalence Study of Enoxaparin Sodium Pre-filled Syringes BP (Injection) 40 mg/0.4 ml (4,000 IU/0.4 mL) of Venus Remedies Limited, India and 'Clexane®' (Enoxaparin Sodium Injection Solution in a Pre-filled Syringe) 4,000 IU (40 mg)/0.4 ml of Sanofi, Germany in Healthy Adult Human Subjects Under Fasting Conditions
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited, India) and its innovator product (Clexane®, Sanofi, Germany).
Read the detailed description
Enoxaparin is a widely used low-molecular-weight heparin (LMWH) obtained by alkaline β-eliminative cleavage of heparin benzyl ester derived from the porcine intestinal mucosa. Currently, several biosimilars/generics of LMWHs with differing potencies are being developed and marketed in various parts of the world. They differ in their PK and PD properties, which could be possibly due to the depolymerization processes or the manufacturing methods that result in its structural variability. Therefore, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule.
The PK properties and bioavailability of LMWHs are routinely determined by pharmacodynamic (PD) surrogates such as Anti-Xa activity, Anti-IIa activity, tissue factor pathway inhibitor (TFPI) and activated partial thromboplastin time (aPTT).
This study was designed as a double-blind, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single-dose pharmacodynamic study in healthy, adult, human subjects under fasting conditions to compare and evaluate the pharmacodynamic profile of test product [Enoxaparin Sodium prefilled syringe BP; 40 mg/0.4 mL (Venus Remedies Limited, India)] with that of reference product ['Clexane®' Enoxaparin Sodium prefilled syringe; 40 mg/0.4 mL (Sanofi, Germany)]. The study was conducted with 24 subjects in accordance with protocol.
After overnight fasting of at least 08 hours, a single dose of either test product or reference product was administered to the subjects slowly by subcutaneous route (shaved abdominal wall) alternated in both period between left or right anterolaterally in a supine posture under the supervision of trained study personnel.
The subjects received the test product (A) and reference product (B) in the study as per the randomization schedule. Participants were randomly selected for one of the two sequences: either AB or BA. The washout period between administration of study drugs in each period was 7 days. Blood samples to assess PD parameters were collected in both study periods at the following time points: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after dosing.
The Anti-Xa and Anti-IIa activity was measured by the chromogenic method using commercial reagent kits - STA®-liquid Anti-Xa, Diagnostica Stago and Actichrome® Heparin (Anti-IIa) kit, Biomedica Diagnostics, respectively. TFPI was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) kit (Quantikine® Human TFPI ELISA kit) and aPTT was determined using clotting assay reagent kit - STA-C.K. Prest® 5-Diagnostica Stago.
Statistical analysis was performed on the pharmacodynamic data to assess bioequivalence between the test product to the reference product. The average bioequivalence of the products was concluded if two-sided 90% CI for the test to the reference ratio of the population means was within 80% and 125% interval for each of the Ln-transformed data, Amax and AUECt for Anti-Xa and Anti-IIa (primary objective).
- Conditions
- Healthy
- Being tested
- Enoxaparin Sodium (Venus Remedies Limited), Enoxaparin Sodium (Sanofi)
- Keywords
- enoxaparin, low molecular weight heparin, bioequivalence, anticoagulant, antithrombotic, heparin, pharmacodynamic equivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Sodium (Venus Remedies Limited)Drug
Also called Cloti-Xa
The test drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Venus Remedies Limited, India
Enoxaparin Sodium (Sanofi)Drug
Also called Clexane
The reference drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Sanofi, Germany
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AB treatment sequence | Experimental | Period 1 - Test Product (A): Enoxaparin Sodium pre-filled syringe BP 40 mg/0.4 ml of Venus Remedies Limited, India.
Period 2 - Reference Product (B): 'Clexane®' (Enoxaparin Sodium pre-filled syringe; 40 mg/0.4 ml) of Sanofi, Germany. Receives: Drug: Enoxaparin Sodium (Venus Remedies Limited); Drug: Enoxaparin Sodium (Sanofi) |
| Cohort 2 - BA treatment sequence | Experimental | Period 1 - Reference Product (B): 'Clexane®' (Enoxaparin Sodium pre-filled syringe; 40 mg/0.4 ml) of Sanofi, Germany.
Period 2 - Test Product (A): Enoxaparin Sodium pre-filled syringe BP 40 mg/0.4 ml of Venus Remedies Limited, India. Receives: Drug: Enoxaparin Sodium (Venus Remedies Limited); Drug: Enoxaparin Sodium (Sanofi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amax for Anti-Xa and Anti-IIa
Maximum measured Anti-Xa and Anti-IIa plasma activity over the time span specified
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
AUECt for Anti-Xa and Anti-IIa
The area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method, for Anti-Xa and Anti-IIa
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Secondary outcomes (7)
AUECi for Anti-Xa and Anti-IIa
The area under the activity/concentration-time curve from time 0 extrapolated to infinity, for Anti-Xa and Anti-IIa
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Tmax for Anti-Xa and Anti-IIa
Tmax is the time to Amax for Anti-Xa and Anti-IIa
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
t1/2 for Anti-Xa and Anti-IIa
apparent first order terminal elimination half-life for Anti-Xa and Anti-IIa
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Kel for Anti-Xa and Anti-IIa
The terminal elimination rate constant obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base e) of the activity versus time plot for these points
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Amax for ratio of Anti-Xa/Anti-IIa activity, TFPI (Baseline corrected and baseline uncorrected) and aPTT (Baseline corrected and baseline uncorrected).
Maximum activity for ratio of Anti-Xa/Anti-IIa and TFPI over the time span specified; maximum clotting time for aPTT
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
AUECt for ratio of Anti-Xa/Anti-IIa activity, TFPI (Baseline corrected and baseline uncorrected) and aPTT (Baseline corrected and baseline uncorrected)
The area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method, for ratio of Anti-Xa/Anti-IIa activity, TFPI (Baseline corrected and baseline uncorrected) and aPTT (Baseline corrected and baseline uncorrected)
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
AUECi for ratio of Anti-Xa/Anti-IIa activity and TFPI (Baseline corrected and baseline uncorrected)
AUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity, for ratio of Anti-Xa/Anti-IIa activity and TFPI (Baseline corrected and baseline uncorrected)
Measured: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start26 Feb 2021
- Primary completion7 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Remedies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Mayur Soni, Principal investigator, Cliantha Research Limited, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265676
- Sponsor's protocol ID
- C1B00548
- Status last verified
- Feb 2022
- First submitted
- 22 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saxena S, Chaudhary M, Chaudhary S, Aggarwal A. Bioequivalence of a biosimilar enoxaparin (Cloti-Xa) and its innovator (Clexane(R) ): A single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced study in healthy human subjects. Pharmacol Res Perspect. 2022 Aug;10(4):e00979. doi: 10.1002/prp2.979.
PubMed 35762448
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover, Balanced, Single Subcutaneous Dose Pharmacodynamic Comparative Equivalence Study of Enoxaparin Sodium Pre-filled Syringes BP (Injection) 40 mg/0.4 ml (4,000 IU/0.4 mL) of Venus Remedies Limited, India and 'Clexane®' (Enoxaparin Sodium Injection Solution in a Pre-filled Syringe) 4,000 IU (40 mg)/0.4 ml of Sanofi, Germany in Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05265676
- Acronym / sponsor ID
- C1B00548
- Conditions
- Healthy
- Keywords
- enoxaparin, low molecular weight heparin, bioequivalence, anticoagulant, antithrombotic, heparin, pharmacodynamic equivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Venus Remedies LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 3 Mar 2022 (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.
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited, India) and its innovator product (Clexane®, Sanofi, Germany).
Detailed description
Enoxaparin is a widely used low-molecular-weight heparin (LMWH) obtained by alkaline β-eliminative cleavage of heparin benzyl ester derived from the porcine intestinal mucosa. Currently, several biosimilars/generics of LMWHs with differing potencies are being developed and marketed in various parts of the world. They differ in their PK and PD properties, which could be possibly due to the depolymerization processes or the manufacturing methods that result in its structural variability. Therefore, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule.
The PK properties and bioavailability of LMWHs are routinely determined by pharmacodynamic (PD) surrogates such as Anti-Xa activity, Anti-IIa activity, tissue factor pathway inhibitor (TFPI) and activated partial thromboplastin time (aPTT).
This study was designed as a double-blind, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single-dose pharmacodynamic study in healthy, adult, human subjects under fasting conditions to compare and evaluate the pharmacodynamic profile of test product [Enoxaparin Sodium prefilled syringe BP; 40 mg/0.4 mL (Venus Remedies Limited, India)] with that of reference product ['Clexane®' Enoxaparin Sodium prefilled syringe; 40 mg/0.4 mL (Sanofi, Germany)]. The study was conducted with 24 subjects in accordance with protocol.
After overnight fasting of at least 08 hours, a single dose of either test product or reference product was administered to the subjects slowly by subcutaneous route (shaved abdominal wall) alternated in both period between left or right anterolaterally in a supine posture under the supervision of trained study personnel.
The subjects received the test product (A) and reference product (B) in the study as per the randomization schedule. Participants were randomly selected for one of the two sequences: either AB or BA. The washout period between administration of study drugs in each period was 7 days. Blood samples to assess PD parameters were collected in both study periods at the following time points: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after dosing.
The Anti-Xa and Anti-IIa activity was measured by the chromogenic method using commercial reagent kits - STA®-liquid Anti-Xa, Diagnostica Stago and Actichrome® Heparin (Anti-IIa) kit, Biomedica Diagnostics, respectively. TFPI was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) kit (Quantikine® Human TFPI ELISA kit) and aPTT was determined using clotting assay reagent kit - STA-C.K. Prest® 5-Diagnostica Stago.
Statistical analysis was performed on the pharmacodynamic data to assess bioequivalence between the test product to the reference product. The average bioequivalence of the products was concluded if two-sided 90% CI for the test to the reference ratio of the population means was within 80% and 125% interval for each of the Ln-transformed data, Amax and AUECt for Anti-Xa and Anti-IIa (primary objective).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AB treatment sequence | Experimental | Drug: Enoxaparin Sodium (Venus Remedies Limited), Drug: Enoxaparin Sodium (Sanofi)Period 1 - Test Product (A): Enoxaparin Sodium pre-filled syringe BP 40 mg/0.4 ml of Venus Remedies Limited, India. Period 2 - Reference Product (B): 'Clexane®' (Enoxaparin Sodium pre-filled syringe; 40 mg/0.4 ml) of Sanofi, Germany. |
| Cohort 2 - BA treatment sequence | Experimental | Drug: Enoxaparin Sodium (Venus Remedies Limited), Drug: Enoxaparin Sodium (Sanofi)Period 1 - Reference Product (B): 'Clexane®' (Enoxaparin Sodium pre-filled syringe; 40 mg/0.4 ml) of Sanofi, Germany. Period 2 - Test Product (A): Enoxaparin Sodium pre-filled syringe BP 40 mg/0.4 ml of Venus Remedies Limited, India. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- Volunteers must not be enrolled in the study if they meet any one of the following criteria:
- History of hypersensitivity or idiosyncratic reaction to Enoxaparin Sodium, pork, heparin or its derivatives, other low molecular weight heparins or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination (for female volunteers)].
- Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History or presence of bronchial asthma.
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 Sodium (Venus Remedies Limited)Also: Cloti-XaThe test drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Venus Remedies Limited, India | Drug | Cohort 1 - AB treatment sequence, Cohort 2 - BA treatment sequence |
| Enoxaparin Sodium (Sanofi)Also: ClexaneThe reference drug is enoxaparin sodium pre-filled syringe 40 mg/0.4mL of Sanofi, Germany | Drug | Cohort 1 - AB treatment sequence, Cohort 2 - BA treatment sequence |
Primary outcome
Amax for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Maximum measured Anti-Xa and Anti-IIa plasma activity over the time span specified
AUECt for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
The area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method, for Anti-Xa and Anti-IIa
7 secondary outcomes
AUECi for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Tmax for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
t1/2 for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Kel for Anti-Xa and Anti-IIa
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Amax for ratio of Anti-Xa/Anti-IIa activity, TFPI (Baseline corrected and baseline uncorrected) and aPTT (Baseline corrected and baseline uncorrected).
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
AUECt for ratio of Anti-Xa/Anti-IIa activity, TFPI (Baseline corrected and baseline uncorrected) and aPTT (Baseline corrected and baseline uncorrected)
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
AUECi for ratio of Anti-Xa/Anti-IIa activity and TFPI (Baseline corrected and baseline uncorrected)
Time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 35762448Saxena S, Chaudhary M, Chaudhary S, Aggarwal A. Bioequivalence of a biosimilar enoxaparin (Cloti-Xa) and its innovator (Clexane(R) ): A single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced study in healthy human subjects. Pharmacol Res Perspect. 2022 Aug;10(4):e00979. doi: 10.1002/prp2.979.
- Individual participant dataSharing planned: No
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RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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. This study is not recruiting at the moment.
Dr. Mayur Soni principal investigator
Cliantha Research Limited, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enoxaparin Sodium (Venus Remedies Limited) and Enoxaparin Sodium (Sanofi) in people with Healthy, run by Venus Remedies Limited at 1 site in India.
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 0 inclusion and 32 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: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amax for Anti-Xa and Anti-IIa (time frame: pre-dose (0.0 hour) and at 0.5, 1.0, 1.5, 2.0, 2.333, 2.667, 3.0, 3.333, 3.667, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 hours after drug administration). 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?
On the ClinicalTrials.gov record for NCT05265676, which also lists 1 linked publication.
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 3 Mar 2022.