Status:
COMPLETED
Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects
Lead Sponsor:
Venus Remedies Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
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 biosi...
Eligibility Criteria
Inclusion
- Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- Age: 18 to 45 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female.
- A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first dosing day. They must be using an acceptable form of contraception.
- B. For female of childbearing potential, acceptable forms of contraception include the following:
- i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
- iii. Surgical sterilization or
- iv. Practicing sexual abstinence throughout the course of the study.
- C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- i. Postmenopausal with spontaneous amenorrhea for at least one year, or
- ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- iii. Total hysterectomy and an absence of bleeding for at least 3 months.
- BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- Volunteer with at least 50 kg weight
- Able to read \& understand informed consent document and give written informed consent to participate in the study
- Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
- Non-alcoholic users will be eligible to participate in this study (i.e. having no past history of drinking alcohol for at least one year prior to study).
- Able to communicate effectively with study personnel.
- Willing to provide written informed consent to participate in the study.
- All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
- A physical examination (clinical examination) with no clinically significant finding.
- Results within normal limits or clinically non-significant for the following tests: haematology, biochemistry, serology, coagulogram and urinalysis
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05265676
Start Date
February 26 2021
End Date
March 11 2021
Last Update
March 3 2022
Active Locations (1)
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1
Cliantha Research Limited
Ahmedabad, Gujarat, India, 380054