The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
33
100 mg oral tablet, single dose
Lacosamide 2 X 100 mg tablet
Lacosamide 4 X 100mg tablet
Unnamed facility
Neuss, Germany
Maximum drug concentration (Cmax) of lacosamide in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent total body clearance (CL/F) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent volume of distribution (Vz/F) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Mean resident time (MRT) of lacosamide in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of lacosamide in plasma
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Placebo - 3 tablets
Placebo - 4 tablets
Placebo - 2 tablets
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Maximum drug concentration (Cmax) of SPM12809 in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Fraction of dose excreted in urine (fe) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Renal clearance (CLR) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent formation clearance of metabolites (CLfm/F)
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
AUC Ratio
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period