Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

Seizures Clinical Trial

Official title:

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826722
• Other study ID #: LEVE-T1000-PVFS-1
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: January 19, 2018
• Start date: June 2007
• Est. completion date: June 2007

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• Levetiracetam
1000 mg tablet

Locations

Country	Name	City	State
United States	Novum Pharmaceutical Research Services	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence based on Cmax		10 days