The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.
Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.
1
Shanghai, China
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Area under the plasma drug concentration-time curve from 0 to infinity (AUC)
The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Maximum measured plasma concentration (Cmax)
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))
The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.
Time frame: Pharmacokinetic samples were taken at 45 min after Levetiracetam administration
Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Terminal half-life of Levetiracetam (t1/2)
The terminal half-life associated with the terminal rate constant λ\_z is calculated as: ln2/λ\_z. λ\_z is the first order rate constant of elimination.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Total body clearance after intravenous infusion of Levetiracetam (CL(iv))
The CL(iv) is calculated as: CL=Dose of LEV/AUC.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))
The CL/F (tablet) is calculated as: CL/F=Dose of LEV/AUC.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))
The volume of distribution after iv infusion is calculated as: Vz=CL/λ\_z, where CL is the total body clearance and λ\_z the first order rate constant of elimination.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))
The apparent volume of distribution after oral administration is calculated as: Vz/F= (CL/F)/λ\_z.
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration