Levetiracetam 1000 mg Under Fasting Conditions

NCT00859521 | Completed Phase 1 Results

• 1 other identifier: 20-116-SA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

THe objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 36 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 36 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Bioequivalence based on AUC0-t

  Blood samples collected over 36 hour period

Study Arms (2)

Levetiracetam

EXPERIMENTAL

Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period

Drug: Levetiracetam

Keppra®

ACTIVE COMPARATOR

Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period

Drug: Keppra®

Interventions

Levetiracetam DRUG

1000 mg Tablet

Levetiracetam

Keppra® DRUG

1000 mg Tablet

Keppra®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must satisfy the following criteria to be considered for study participation:
• Subject must be male or non-pregnant, non-breast-feeding female
• Subject must be at least 18 years of age
• Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs)
• Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
• Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures.
• Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits.

You may not qualify if:

• Subjects may be excluded for any of the following:
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
• Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
• History or presence of allergic or adverse response to levetiracetam or related drugs.
• Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
• Has donated blood or plasma within 30 days prior to the first dose of study medication.
• Has participated in another clinical trial within 30 days prior to the first dose of study medication.
• Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
• Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
• Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
• Has smoked or used tobacco products within 90 days prior to the first dose of study medication.
• Subject has consumed alcohol, caffeine/xanthine, or grapefruit containing beverages and foods from 48 hours prior to the dose of study medication and throughout the sample collection period.
• Is a female with a positive pregnancy test result.
• Female who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study start.
• Has an intolerance to venipuncture.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

CEDRA Clinical Research, LLC

San Antonio, Texas, 78217, United States

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

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James P Doherty, D.O.

  CEDRA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: January 1, 2007
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: August 20, 2024
• Results First Posted: August 25, 2009

Record last verified: 2024-08

Locations

US (1)