None listed
Conditions
Interventions
Intervention1: Ovine Enoxaparin sodium 60 mg/0.6 mL, solution for
injection: Dosing Strength: 60 mg/0.6 mL.
Dosage Form: Solution for injection.
Route of Administration:Subcutaneous
Control Interventi
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult human subjects between 18-45 years of age (including both). 2. Subjects able to communicate effectively. 3. Voluntary participation. 4. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 5. Body mass index in the range of 18.5 to 29.9 kg per m and weight should be greater than or equal to 50 kgs for females and greater than or equal to 60 kgs for males. 6. Creatinine clearance greater than 80ml/min. 7. Normal 12-lead ECG. 8. Normal chest X-ray. 9. Normal laboratory parameters. 10. Non-smokers and non-alcoholics. 11. Absence of disease markers of HIV 1 & 2, hepatitis B and C virus and VDRL. 12. Subject willing to abstain from all kinds of St. Johns wort or grapefruit or citrus containing foods or juices from 07 days prior to period-01 admission until the last post dose blood sample collection in each study period and caffeine/xanthine containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) from 72.00 hours prior to admission until the last post dose blood sample collection in each study period. 13. Female subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion criteria
Exclusion criteria: 1. Volunteers with a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to Enoxaparin or related class of drugs and any of its ingredients. 2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic impairment (such as Child-Pugh Class C), renal impairment, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. 3. History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine. 4. History of immune mediated heparin-induced thrombocytopenia (HIT). 5. History of acute infective endocarditis or use of mechanical prosthetic valves. 6. History or evidence of exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). 7. Significant bleeding disorders, thrombocytopenia, blood clothing disorders, increased risk of bleeding or conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. 8. Presence of active clinically significant bleeding. 9. Spinal or epidural anaesthesia or loco-regional anaesthesia in the last 07 days prior to period 01 admission and not planned for spinal or epidural anaesthesia or loco-regional anaesthesia until 07 days after the last dose. 10. Any known enzyme inducing or inhibiting drug taken within 14 days before the study. 11. Participation in a drug research study within 90 days prior to dosing of this study. 12. Blood loss (more than 100 ml) or whole blood donation within 90 days prior to dosing. 13. A depot injection or implant of any drug within 3 months prior to the first dose of study medication. 14. History of addiction to any recreational drug or drug dependence. 15. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons. 16. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each study period. 17. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period. 18. Positive results for alcohol consumption during the admission of each study period. 19. Intolerance to venipuncture. 20. Difficulty with donating blood. 21. Difficulty in swallowing investigational products. 22. Blood pressure on the day of admission of each study period. a. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. b. Dias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters: AUC0-t and Amax (maximum activity observed) of anti-Xa and anti-IIaTimepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| TFPI (Tissue Factor Pathway Inhibitor) activityTimepoint: 24 hours | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed