A randomized, open-label, crossover study to compare the ratio of pharmacokinetics between Orgaran® and Clexane® in healthy subjects with an historical study.
Completed
- Conditions
- Tromboseblood cloths
- Registration Number
- NL-OMON46006
- Lead Sponsor
- Aspen Global Incorporated (AGI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
healthy male subjects
18-30 years of age
BMI 18.0-30.0 kg/m2
non smokers or less than 10 cigarettes per day
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the ratio of maximum observed concentration in plasma (Cmax) and<br /><br>area under the concentration-time curve (AUC) of anti-factor Xa activity of<br /><br>3750 Anti-Factor Xa units (U) Orgaran® intravenous (iv) to 40 mg Clexane® iv in<br /><br>healthy subjects, between the current study and Study 62006.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate dose linearity and pharmacokinetics (PK) of thrombin generation<br /><br>inhibition (TGI) and other hemostasis parameters after intravenous<br /><br>administration of 3 dose levels of Orgaran® in healthy subjects.<br /><br>To evaluate the safety and tolerability of Orgaran® in healthy subjects.<br /><br>To compare the ratio of other hemostasis parameters of Orgaran® to Clexane® in<br /><br>healthy subjects, between the current study and Study 62006.</p><br>