An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
- Registration Number
- NCT01618903
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Chinese, age 18-40, weight ≥ 50 kg
- Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test
- History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- History or presence of drug addiction or excessive use of alcohol
- Symptomatic or asymptomatic Orthostatic Hypotension at screening
- Current smokers and former smokers
- Heavy caffeine drinker
- History of frequent and severe headache
- Any drug treatment
- Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
- Subjects on a controlled sodium diet
- Subject has made a blood donation or had a comparable blood loss
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Levetiracetam iv infusion Levetiracetam Levetiracetam intravenous (iv) 45 min infusion administered as one single dose. Levetiracetam oral tablet Levetiracetam Levetiracetam oral tablet administered as one single dose.
- Primary Outcome Measures
Name Time Method Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t)) 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) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration 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.
Maximum measured plasma concentration (Cmax) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
- Secondary Outcome Measures
Name Time Method Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12)) 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)) Pharmacokinetic samples were taken at 45 min after Levetiracetam administration 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 to reach the maximum plasma concentration of Levetiracetam after administration (tmax) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration Terminal half-life of Levetiracetam (t1/2) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration 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.
Total body clearance after intravenous infusion of Levetiracetam (CL(iv)) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration The CL(iv) is calculated as:
CL=Dose of LEV/AUC.Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet)) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration The CL/F (tablet) is calculated as:
CL/F=Dose of LEV/AUC.Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv)) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration 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.Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet)) Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration The apparent volume of distribution after oral administration is calculated as:
Vz/F= (CL/F)/λ_z.
Trial Locations
- Locations (1)
1
🇨🇳Shanghai, China