Phase 1
N=47
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Enoxaparin Sodium is Administered to Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02232802 ↗Enrolled (actual)
47
Serious AEs
2.2%
Results posted
Oct 2020
Primary outcome: Primary: Cmax (Anti-FXa and Anti-FIIa) — 0.8593; 0.8698; 0.1187; 0.1296 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Enoxaparin Sodium (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chemi S.p.A.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Anti-FXa and Anti-FIIa) |
0.8593; 0.8698; 0.1187; 0.1296 | — |
| PRIMARY AUC0-t (Anti-FXa and Anti-FIIa) |
9.6259; 9.3927; 1.0234; 1.1097 | — |
| SECONDARY AUC0-inf (Anti-FXa and Anti-FIIa) |
10.2789; 9.9197; 1.1489; 1.2926 | — |
| SECONDARY Tmax (Anti-FXa and Anti-FIIa) |
4.0000; 4.0000; 4.0000; 4.0000 | 0.7642 |
| SECONDARY Lambda Zeta (Anti-FXa and Anti-FIIa) |
0.0962; 0.1133; 0.2111; 0.1938 | — |
| SECONDARY t1/2 (Anti-FXa and Anti-FIIa) |
8.4757; 6.9507; 4.6214; 6.5045 | — |
| SECONDARY Tmin (Anti-FXa and Anti-FIIa) |
0.00; 0.00; 4.18; 6.91 | — |
| SECONDARY AUC%ex (Anti-FXa and Anti-FIIa) |
6.4515; 4.9683; 12.0593; 12.0906 | — |
| SECONDARY Cmin (Anti-FXa and Anti-FIIa) |
0.000; 0.000; 0.002; 0.002 | — |
| SECONDARY Cmax (Tissue Factor Pathway Inhibitor, TFPI) |
2.4327; 2.3391 | — |
| SECONDARY Cmax (Anti-FXa/Anti-FIIa Ratio) |
7.4450; 6.8546 | — |
| SECONDARY AUC0-t (Derived Thrombin Generation) |
3731.0710; 3597.3375 | — |
| SECONDARY Cmin (Derived Thrombin Generation) |
13.534; 11.543 | — |
| SECONDARY Tmin (Derived Thrombin Generation) |
3.67; 3.64 | = 0.8554 |
| SECONDARY AUC0-t (Tissue Factor Pathway Inhibitor, TFPI) |
56.1828; 55.7851 | — |
| SECONDARY AUC0-inf (Tissue Factor Pathway Inhibitor, TFPI) |
140.8383; 173.9833 | — |
| SECONDARY Tmax (Tissue Factor Pathway Inhibitor, TFPI) |
1.7500; 1.8068 | = 0.6857 |
| SECONDARY Cmin (Tissue Factor Pathway Inhibitor, TFPI) |
1.261; 1.290 | — |
| SECONDARY Tmin (Tissue Factor Pathway Inhibitor, TFPI) |
16.27; 15.55 | — |
| SECONDARY T1/2 (Tissue Factor Pathway Inhibitor, TFPI) |
41.6397; 57.2439 | — |
| SECONDARY Lambda Zeta (Tissue Factor Pathway Inhibitor, TFPI) |
0.0172; 0.0148 | — |
| SECONDARY AUC%ex (Tissue Factor Pathway Inhibitor, TFPI) |
58.9149; 63.0497 | — |
| SECONDARY AUC0-t (Anti-FXa/Anti-FIIa Ratio) |
9.7836; 8.7967 | — |
| SECONDARY AUC0-inf (Anti-FXa/Anti-FIIa Ratio) |
9.1620; 8.2160 | — |
| SECONDARY T1/2 (Anti-FXa/Anti-FIIa Ratio) |
2.6595; 1.9420 | — |
| SECONDARY Cmin (Anti-FXa/Anti-FIIa Ratio) |
0.000; 0.000 | — |
| SECONDARY Tmin (Anti-FXa/Anti-FIIa Ratio) |
0.00; 0.00 | — |
| SECONDARY AUC%ex (Anti-FXa/Anti-FIIa Ratio) |
0.8078; 0.6385 | — |
| SECONDARY Tmax (Anti-FXa/Anti-FIIa Ratio) |
0.9973; 0.9830 | = 0.9217 |
| SECONDARY Lambda Zeta (Anti-FXa/Anti-FIIa Ratio) |
0.6699; 1.0937 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02232802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.