Human Volunteers
Conditions
Keywords
Keppra Levetiracetam intravenous, Oral tablets, Bioequivalence, Pharmacokinetics, Safety, Chinese healthy volunteers
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.
Interventions
DRUGLevetiracetam
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.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed