Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

N/ACompletedNCT00826865

Roxane Laboratories27 enrolled

Overview

The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fasted conditions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seizures

Interventions

LevetiracetamDRUG

750 mg tablet

Eligibility

Sex: FEMALEMin 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)

MDS Pharma Services

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

bioequivalance based on Cmax

Time frame: 10 days

Data from ClinicalTrials.gov

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