Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

Healthy Volunteers Clinical Trial

Official title:

A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394224
• Other study ID #: N01377
• Secondary ID: 2011-000827-34
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2011
• Last updated: October 5, 2011
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion Criteria:

• Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months

• Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)

• Subject is pregnant or lactating female.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Levetiracetam
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
• Levetiracetam
Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum drug concentration (Cmax)		Multiple sampling from 0 to 36 hours following single dose	No
Primary	Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)		Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose	No
Secondary	Time to reach maximum plasma concentration (tmax)		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	Plasma concentration at the end of infusion (C15' )		At 15 minutes after termination of the15-minutes infusion	No
Secondary	Area under the curve from 0 to infinity (AUC)		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	Mean resident time (MRT)		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	Terminal elimination half-life(t1/2)		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	First order terminal elimination rate constant (?z )		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	Total body clearance after oral administration (CL/F) or after IV infusion (CL)		Multiple sampling from 0 to 36 hours following single dose	No
Secondary	Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)		Multiple sampling from 0 to 36 hours following single dose	No