A study comparing Clexane and Chemi's enoxaparin in healthy volunteers
Research type
Research Study
Full title
Comparative, randomized, single-dose, 2-way cross over bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8mL) and Clexane® (80 mg/0.8mL) s.c. in healthy adult subjects under fasting conditions.
IRAS ID
160280
Contact name
Salvatore Febbraro
Contact email
Sponsor organisation
Chemi S.p.A (Part of Italfarmaco group)
Eudract number
2014-002690-11
Research summary
The purpose of this study is to assess the effects of Clexane® on the blood and compare it against Enoxaparin sodium Chemi. Chemi S.p.A is the pharmaceutical company who are sponsoring this study. Clexane® and Enoxaparin sodium Chemi contain the same active ingredient called enoxaparin sodium, which belongs to a group of medicines called Low Molecular Weight Heparins. This medicine is used for prophylaxis (Disease prevention) and treatment of thromboembolic disorders of a venous origin such as deep vein thrombosis. Blood samples will be collected to measure biochemical markers, these biochemical markers show the amount of blood clotting factors found in the blood. Comparisons will be made between the results following administration of Clexane® and Enoxaparin sodium Chemi.
The dose will be 80 mg, which equates to 80mg in a 0.8ml injection. The reason for this concentration being selected is because it is within the range of doses approved for Clexane and because it can ensure that the pharmacodynamic/pharmacokinectic parameters are assessed(to confirm what the drug does to the body).
The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 55 years, as determined by screening tests at Simbec.
The study will consist of two treatment periods. Each treatment period will begin in the afternoon of Day -1, and involve 2 overnight stays at Simbec (Day-1 to Day 2). There be at least a 7 day washout period between the administration of Clexane in treatment period 1 and treatment period 2. Female subjects (Of child-bearing potential) will return 28 days after treatment period 1 for their treatment period 2. The end of study/post study assessment will be performed at the end of treatment period 2.
Participation in the trial will last for about 4 weeks (from first screening visit to final study visit).
REC name
Wales REC 2
REC reference
14/WA/1044
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion