Human Volunteers
Conditions
Keywords
Keppra Levetiracetam intravenous, Multiple dose, Safety, Pharmacokinetics, Chinese healthy volunteers
Brief summary
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the 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 every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
OTHERPlacebo
15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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-time curve over a dosing interval (AUCτ) | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 | The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ. |
| Maximum measured plasma concentration (Cmax) | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 | The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv)) | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 | 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. |
| Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin) | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 | — |
| Terminal half-life (t1/2) | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 | 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. |
Countries
China
Outcome results
None listed