Status:
COMPLETED
Pharmacodynamic Equivalence of Ovine Enoxaparin to Lovenox®
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
PT Metiska Farma
Conditions:
Enoxaparin
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief 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 / pharma...
Detailed Description
Low molecular-weight heparins (LMWHs) are derived from unfractionated heparin (UFH) by chemical or enzymatic depolymerization. Enoxaparin is one of the most widely used LMWHs and is obtained by alkali...
Eligibility Criteria
Inclusion
- Healthy volunteers of both sexes aged 18 - 45 years with BMI 18 - 25 kg/m2 inclusive.
- Have no clinically significant abnormalities based on medical history, clinical laboratory tests, vital sign measurements, 12-lead ECG results, and physical examination findings.
- Willing to participate in the study by signing the informed consent.
Exclusion
- Female \< 45 kg or male \< 57 kg
- Calculated (Cockroft \& Gault formula) ClCr \< 80 mL/min
- History of or positive test result for alcohol abuse or drug addiction.
- History of relevant drug and/or food allergies.
- 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.
- Administration of any investigational drug within 60 days before study drug dosing.
- Taking anti TB rifampicin within 60 days before study drug dosing.
- A positive test for HIV (1 or 2) Ab, HBsAg, or HepC Ab.
- A positive fecal occult blood at screening.
- History and/or current conditions of bleeding tendency.
- History of thrombocytopenia, including heparin-induced (by anamnesis).
- Known history of hypersensitivity to drugs with a chemical structure similar to enoxaparin sodium (eg. UFH, LMWH) or to pork or lamb products.
- Females: - during menstruation period
- Pregnancy or lactation
- taking hormonal contraception (oral or injection)
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04402762
Start Date
December 20 2019
End Date
May 3 2020
Last Update
May 27 2020
Active Locations (1)
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1
Pharma Metric Labs
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10520