The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.
EP0110 1
Sumida-ku, Japan
Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
Cmax is the maximum plasma concentration of brivaracetam.
Time frame: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
Time frame: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
An AE was defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.
Time frame: From Baseline to end of Safety Follow-Up, up to 20 days
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)
A TEAE was any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization,Is a congenital anomaly or birth defect, Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
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Time frame: From Baseline to end of Safety Follow-Up, up to 20 days