Protocol CV185074: evaluation of multiple dose pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban in healthy subjects

Protocol CV185074: evaluation of multiple dose pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban in healthy subjects - Apixaban/Rivaroxaban multiple dose PK/PD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34739

Enrollment

Registered

2010-01-18

Start date

2010-01-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Veneuze trombose Trombose

Interventions

Study Medication Active substance: Rivaroxaban and Apixaban.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male/female - age between 18 and 45 years old - BMI between 18 and 30 kg/m2 - non-smoker - at screening state of health must satisfy the entry requirements

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 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 (for men) / more than 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics. Pharmacokinetics. Safety.	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)