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

Completed

• Conditions: Epilepsy; seizures (attacks); 10039911

• Registration Number: NL-OMON37817
• Lead Sponsor: CB Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK, PD, Safety and tolerability.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a.</p><br>