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

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: NCT01618877
• Other study ID #: N01362B
• 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 B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the 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: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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 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).

Other:
• Placebo
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).

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-time curve over a dosing interval (AUCt)	The AUCt is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval t.	Pharmacokinetic samples were taken 36 hours after iv administration on Day 7	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 36 hours after iv administration on Day 7	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 36 hours after iv administration on Day 7	No
Secondary	Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin)		Pharmacokinetic samples were taken 36 hours after iv administration on Day 7	No
Secondary	Terminal half-life (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 36 hours after iv administration on Day 7	No

External Links

•   FDA Safety Alerts and Recalls
•   Keppra IV