Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00826722
Collaborator
(none)
30
1
Study Details
Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fasted conditions
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fasting Conditions
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
Jun 1, 2007
Actual Study Completion Date
:
Jun 1, 2007
Outcome Measures
Primary Outcome Measures
- bioequivalence based on Cmax [10 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novum Pharmaceutical Research Services | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Soran Hong, MD, Novum Pharmaceutical Research Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00826722
Other Study ID Numbers:
- LEVE-T1000-PVFS-1
First Posted:
Jan 22, 2009
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018