SINGLE CENTER, OPEN LABEL, RANDOMIZED TWO-WAY CROSSOVER STUDY OF THE EFFECT OF LACOSAMIDE 200MG TWICE DAILY ON THE SINGLE-DOSE PHARMACOKINETICS AND PHARMACODYNAMICS OF WARFARIN (25 MG) IN HEALTHY MALE VOLUNTEERS

SINGLE CENTER, OPEN LABEL, RANDOMIZED TWO-WAY CROSSOVER STUDY OF THE EFFECT OF LACOSAMIDE 200MG TWICE DAILY ON THE SINGLE-DOSE PHARMACOKINETICS AND PHARMACODYNAMICS OF WARFARIN (25 MG) IN HEALTHY MALE VOLUNTEERS - Lacosamide/Warfarin DDI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37817

Enrollment

Registered

2012-01-06

Start date

2012-01-16

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

Epilepsy seizures (attacks)

Interventions

n/a.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Male between18-55 yrs,, 18.0-30.0 kg/m2, with a body weight of at least 50 kg. Non-smoking

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, C, 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 or in case of donating more than 1.5 liter of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
PK, PD, Safety and tolerability.	—

Secondary

Measure	Time frame
n/a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)