The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing in healthy Chinese male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Sp1001 001
Shanghai, China
Maximum plasma concentration (Cmax) of Lacosamide (LCM)
Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])
Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)
Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Terminal plasma elimination half-life (t1/2) of LCM
Terminal elimination half-life of LCM, reported in hours, as determined via simple linear regression(slope=-z) of natural log (ln) concentration vs time for data points in the terminal phase of the concentration-time curve. t½ is calculated as ln(2)/z.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Time of observed Cmax (tmax) of LCM
Time of observed Cmax will be obtained directly from the plasma concentration-time curves.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
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Apparent plasma clearance (CL/F) of LCM
Apparent plasma clearance calculated as CL/F=Dose/AUC.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Apparent volume of distribution (Vz/F) of LCM
Apparent volume of distribution, calculated as Vz/F=(CL/F)/z.
Time frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing