Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox®

• Status: Completed
• Trial end date: 2020-05-03
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a randomized, open-label, 2-way cross-over, single dose study with at least 7 days wash-out period. The objective of this study is to demonstrate the pharmacodynamic / pharmacokinetic equivalence of ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Collaborator: PT Metiska Farma
• Treatments: Enoxaparin; Enoxaparin sodium

Criteria

Inclusion Criteria:

1. Healthy volunteers of both sexes aged 18 - 45 years with BMI 18 - 25 kg/m2 inclusive.

2. Have no clinically significant abnormalities based on medical history, clinical laboratory tests, vital sign measurements, 12-lead ECG results, and physical examination findings.

3. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

1. Female < 45 kg or male < 57 kg

2. Calculated (Cockroft & Gault formula) ClCr < 80 mL/min

3. History of or positive test result for alcohol abuse or drug addiction.

4. History of relevant drug and/or food allergies.

5. Any prescription drug (especially antiplatelet or anticoagulant drug) or OTC medication including herbal, supplement, etc. that could affect coagulation within 2 weeks before study dosing.

6. Administration of any investigational drug within 60 days before study drug dosing.

7. Taking anti TB rifampicin within 60 days before study drug dosing.

8. A positive test for HIV (1 or 2) Ab, HBsAg, or HepC Ab.

9. A positive fecal occult blood at screening.

10. History and/or current conditions of bleeding tendency.

11. History of thrombocytopenia, including heparin-induced (by anamnesis).

12. Known history of hypersensitivity to drugs with a chemical structure similar to enoxaparin sodium (eg. UFH, LMWH) or to pork or lamb products.

13. Females: - during menstruation period

• Pregnancy or lactation

• taking hormonal contraception (oral or injection)