A RANDOMIZED, SINGLE-CENTER, OPEN-LABEL, 5-WAY CROSSOVER, SINGLE-DOSE BIOAVAILABILITY/BIOEQUIVALENCE COMPARISON OF BRIVARACETAM ORAL TABLETS (10MG, 50MG, 75MG, AND 100MG) AND BRIVARACETAM INTRAVENOUS BOLUS INJECTION (100MG) IN HEALTHY VOLUNTEERS

Completed

• Conditions: attacks; 10039911; epileptic seizures

• Registration Number: NL-OMON38511
• Lead Sponsor: CB Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Healthy males and females
18-55 years, incl.
BMI 18.0-30.0 kg/m2 incl.

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>Pharmacokinetics: plasma drug concentrations, pharmacokinetic parameters<br /><br><br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmakinetics parameters: analysis of variance on Cmax and AUC, other<br /><br>parameters descriptive statistics.<br /><br><br /><br>Safety parameters: descriptive statistics.</p><br>