Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

NCT00985348 | Completed Phase 1

• 1 other identifier: N01339
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.

Conditions

Healthy

Keywords

Levetiracetam; Healthy volunteers; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax (maximum plasma concentration) of Levetiracetam.

  36 hours

• AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam

  36 hours

• AUC (Area under the curve extrapolated to infinity) of Levetiracetam

  36 hours

Secondary Outcomes (6)

• tmax (time of maximum plasma concentration) of Levetiracetam

  36 hours

• λz (Terminal elimination rate constant) of Levetiracetam

  36 hours

• t1/2 (Terminal elimination half-life) of Levetiracetam

  36 hours

• MRT (Mean Residence Time) of Levetiracetam

  36 hours

• CL/F (Apparent total body clearance) of Levetiracetam

  36 hours

Study Arms (2)

Treatment 1/Treatment 2

EXPERIMENTAL

Drug: Levetiracetam (Keppra)

Treatment 2/Treatment 1

EXPERIMENTAL

Drug: Levetiracetam (Keppra)

Interventions

Levetiracetam (Keppra) DRUG

Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Also known as: Keppra

Treatment 1/Treatment 2; Treatment 2/Treatment 1

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent dated and signed by subject.
• Healthy male or female Japanese volunteer from the first generation, living outside of Japan for less than 10 years, age range 20 to 55 years inclusive.
• Body Mass Index (BMI) between 18.0 and 28.0 kg/m² inclusive.

You may not qualify if:

• Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication.
• History of drug addiction or presence of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake in excess of 21 units alcohol for male and 14 units alcohol for female; one unit alcohol equals one glass of beer or lager, a glass of wine or a measure of spirits), of psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
• Heavy caffeine drinker (drinking \>5 cups of coffee or equivalent, approximately 500mg of caffeine per day).
• Smokers of more than 10 cigarettes per day or smokers not willing to abstain from smoking while in the clinic for each period.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

GB (1)