Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.

• Status: Completed
• Trial end date: 2014-12-05
• Target enrollment: 0
• Participant gender: All

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, under fasting conditions in healthy volunteers.

• The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.

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

Details

• Lead Sponsor: Chemi S.p.A.
• Treatments: Enoxaparin; Enoxaparin sodium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.