A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

Phase 1

Completed

• Conditions: Human Volunteers
• Interventions: Other: Placebo; Drug: Levetiracetam

• Registration Number: NCT01618877
• Lead Sponsor: UCB Pharma

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo infusion	Placebo	-
Levetiracetam iv infusion	Levetiracetam	Levetiracetam intravenous (iv) infusion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

1; 🇨🇳 Shanghai, China