To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
26
Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose
Unnamed facility
London, United Kingdom
Cmax (maximum plasma concentration) of Levetiracetam.
Time frame: 36 hours
AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam
Time frame: 36 hours
AUC (Area under the curve extrapolated to infinity) of Levetiracetam
Time frame: 36 hours
tmax (time of maximum plasma concentration) of Levetiracetam
Time frame: 36 hours
λz (Terminal elimination rate constant) of Levetiracetam
Time frame: 36 hours
t1/2 (Terminal elimination half-life) of Levetiracetam
Time frame: 36 hours
MRT (Mean Residence Time) of Levetiracetam
Time frame: 36 hours
CL/F (Apparent total body clearance) of Levetiracetam
Time frame: 36 hours
Vz/F (Apparent volume of distribution) of Levetiracetam
Time frame: 36 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.