A randomized, open-label, crossover study to compare the ratio of pharmacokinetics between Orgaran® and Clexane® in healthy subjects with an historical study.

A randomized, open-label, crossover study to compare the ratio of pharmacokinetics between Orgaran® and Clexane® in healthy subjects with an historical study. - Orgaran® PK study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46006

Enrollment

Registered

2017-10-19

Start date

2017-10-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trombose blood cloths

Interventions

Treatment A: 1500 U Orgaran® Once Treatment B: 2250 U Orgaran® Once Treatment C: 3750 U Orgaran® Once Treatment D: 40 mg Clexane® Once

Clexane®

Orgaran®

Thrombosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To compare the ratio of maximum observed concentration in plasma (Cmax) and area under the concentration-time curve (AUC) of anti-factor Xa activity of 3750 Anti-Factor Xa units (U) Orgaran® intravenous (iv) to 40 mg Clexane® iv in healthy subjects, between the current study and Study 62006.	—

Secondary

Measure	Time frame
To investigate dose linearity and pharmacokinetics (PK) of thrombin generation inhibition (TGI) and other hemostasis parameters after intravenous administration of 3 dose levels of Orgaran® in healthy subjects. To evaluate the safety and tolerability of Orgaran® in healthy subjects. To compare the ratio of other hemostasis parameters of Orgaran® to Clexane® in healthy subjects, between the current study and Study 62006.	—

Measure

Time frame

To investigate dose linearity and pharmacokinetics (PK) of thrombin generation inhibition (TGI) and other hemostasis parameters after intravenous administration of 3 dose levels of Orgaran® in healthy subjects. To evaluate the safety and tolerability of Orgaran® in healthy subjects. To compare the ratio of other hemostasis parameters of Orgaran® to Clexane® in healthy subjects, between the current study and Study 62006.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)