Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

Not Applicable

Completed

• Conditions: Seizures

• Registration Number: NCT00826865
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalance based on Cmax	10 days

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Phoenix, Arizona, United States