Single-dose, randomized, double-blind, two-way crossover study for the demonstration of pharmacodynamic equivalence of enoxaparin (100 mg/mL) 100-mg subcutaneous injection. Manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg subcutaneous injection manufactured by Sanofi (EU) in healthy volunteers.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

- Healthy male or female.
- Between 18 and 45 years of age, inclusive.
- BMI is between 18 and 30 kilograms/meter2
- If you are a woman, your weight is > 45 kg, if you are a man, your weight is > 57 kg
- Nonsmoker

Exclusion Criteria

1. Subject has active or recurring clinically significant skin, head, ears, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary, neurologic, hematologic, musculoskeletal, immunologic, allergic, psychological/psychiatric, or other disease requiring medical treatment
2. Subject is a woman who is pregnant or breastfeeding.
3. Subject has systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 90 mm Hg at Screening (confirmed upon repeat measurement).
4. Subject has a calculated (Cockroft & Gault formula) creatinine clearance less than 80 mL/minute and the value does not return to within reference range upon retest.
5. Subject has Hb <7.5 mmol/L and <8.5 mmol/L for female and male.
6. Subject has an active malignancy of any type other than nonmelanomatous skin malignancies.
7. Subject has any history of alcohol abuse or drug addiction.
8. Subject has any history of relevant drug and/or food allergies.
9. Subject has used any prescription drugs (with special attention to antiplatelet or anticoagulant medication, eg, acetyl salicylic acid, NSADs, clopidogrel, warfarin, acenocumarol, heparin, low molecular weight heparin, dabigatran, rivaroxaban, apixaban) or over-the-counter medication that may affect coagulation (including aspirin or NSAIDs) within 4 weeks before dosing, or any other over-the-counter medication (including vitamins, herbal supplements, or dietary supplements) within 2 weeks before dosing.
10. Subject has a positive test result for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, oxycodone), cotinine, or alcohol.
11. Subject has a positive test result for human immunodeficiency virus (1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody.
12. Subject has a positive test for fecal occult blood at Screening.
13. Subject has any history and/or current conditions of bleeding tendency such as: active bleeding, known bleeding diathesis or hemostatic defects due to severe hepatic or renal disease; recent gastrointestinal or genitourinary bleeding (10 days before study entry); diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic conditions.
14. Subject has a known history or family history of any relevant congenital or acquired coagulation disorder (eg, hemophilia, von Willebrand-Jürgens syndrome, or activated protein C resistance based upon Factor V Leiden mutation).
15. Subject has a history of thrombocytopenia, including heparin induced thrombocytopenia.
16. Subject has a known history of hypersensitivity to drugs with a similar chemical structure to enoxaparin sodium (eg, unfractionated heparin, LMWH), or to pork products.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to demonstrate the pharmacodynamic (PD) equivalence<br /><br>of enoxaparin (100 mg/mL) 100-mg SC injection manufactured by Rovi (Spain)<br /><br>to Clexane (100 mg/mL) 100-mg SC injection manufactured by Sanofi (EU) in<br /><br>healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to evaluate the safety and tolerability of enoxaparin<br /><br>(100 mg/mL) 100-mg SC injection manufactured by Rovi, Spain in healthy<br /><br>volunteers.</p><br>