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

NCT01618903 | Completed Phase 1

• 1 other identifier: N01362A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Volunteers

Keywords

Keppra Levetiracetam intravenous; Oral tablets; Bioequivalence; Pharmacokinetics; Safety; Chinese healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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)

  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

• 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

Secondary Outcomes (8)

• 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

• 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

• Total body clearance after intravenous infusion of Levetiracetam (CL(iv))

  Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

Study Arms (2)

Levetiracetam iv infusion

EXPERIMENTAL

Levetiracetam intravenous (iv) 45 min infusion administered as one single dose.

Drug: Levetiracetam

Levetiracetam oral tablet

EXPERIMENTAL

Levetiracetam oral tablet administered as one single dose.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

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.

Also known as: Keppra

Levetiracetam iv infusion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

1

Shanghai, China

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

CN (1)