Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: Seizures

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00826865

LEVE-T750-PVFS-1

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)