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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Volunteers

Intervention: Levetiracetam (Drug); Levetiracetam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

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.

Clinical Details

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

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

Primary outcome:

Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))

Area under the plasma drug concentration-time curve from 0 to infinity (AUC)

Maximum measured plasma concentration (Cmax)

Secondary outcome:

Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))

Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))

Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)

Terminal half-life of Levetiracetam (t1/2)

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

Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))

Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))

Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))

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 pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

1, Shanghai, China
Additional Information

Keppra Tablets/Oral Solution

Keppra IV

FDA Safety Alerts and Recalls

Starting date: May 2012
Last updated: August 2, 2012

Page last updated: August 23, 2015

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