Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

N/ACompletedNCT00827320

Roxane Laboratories26 enrolled

Overview

The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seizures

Interventions

LevetiracetamDRUG

1000 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: * Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Locations (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

bioequivalence based on Cmax

Time frame: 10 days

Data from ClinicalTrials.gov

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