An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese

Human Volunteers Clinical Trial

Official title:

A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618903
• Other study ID #: N01362A
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2012
• Last updated: August 2, 2012
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Human Volunteers

Intervention

Drug:
• Levetiracetam
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
Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.

Locations

Country	Name	City	State
China	1	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Primary	Maximum measured plasma concentration (Cmax)	The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Secondary	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	No
Secondary	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.	Pharmacokinetic samples were taken at 45 min after Levetiracetam administration	No
Secondary	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	No
Secondary	Terminal half-life of Levetiracetam (t1/2)	The terminal half-life associated with the terminal rate constant ?_z is calculated as: ln2/?_z. ?_z is the first order rate constant of elimination.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Secondary	Total body clearance after intravenous infusion of Levetiracetam (CL(iv))	The CL(iv) is calculated as: CL=Dose of LEV/AUC.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Secondary	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.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Secondary	Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))	The volume of distribution after iv infusion is calculated as: Vz=CL/?_z, where CL is the total body clearance and ?_z the first order rate constant of elimination.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No
Secondary	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)/?_z.	Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration	No

External Links

•   FDA Safety Alerts and Recalls
•   Keppra IV
•   Keppra Tablets/Oral Solution