Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Seizures
- Registration Number
- NCT00826722
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fasted conditions
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 bioequivalence based on Cmax 10 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Levetiracetam's SV2A receptor interaction are studied in NCT00826722 bioequivalence trials?
How does the bioavailability of generic vs brand-name Levetiracetam 1g compare under fasting conditions in NCT00826722?
Are there pharmacogenomic biomarkers predicting Levetiracetam response in focal or generalized seizure populations?
What adverse event profiles differentiate Levetiracetam formulations in fasted-state bioequivalence studies?
How does Levetiracetam's anticonvulsant efficacy compare to other pyrrolidone derivatives like Brivaracetam in seizure management?
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Houston, Texas, United States