Status:
COMPLETED
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Lead Sponsor:
Chemi S.p.A.
Conditions:
Enoxaparin Sodium is Administered to Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection,...
Detailed Description
This is an open-label, randomised, single-dose, 2-way crossover study to determine the comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL) with that from the ...
Eligibility Criteria
Inclusion
- Healthy male or female volunteer between 18 and 55 years of age.
- Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / \[Height (m)\]2)
- Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
- Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) and vital signs determined within 14 days of the first dose.
- Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV) results.
Exclusion
- Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.
- Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug abuse;
- Subject with clinically relevant abnormal physical findings or clinically relevant abnormal laboratory values indicative of physical illness;
- Female subject who is pregnant or lactating
- Female subject with weight \< 45 kg or male subject with weight \< 57 kg.
Key Trial Info
Start Date :
August 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02232802
Start Date
August 4 2014
End Date
December 5 2014
Last Update
October 20 2020
Active Locations (1)
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1
Simbec Research Ltd
Merthyr Tydfil, United Kingdom, CF48 4DR