evetiracetam tablet 1000mg (LEVEBEL 1000mg, Cobel Darou) In- Vivo Bioequivalence study in Iranian healthy volunteers
Not Applicable
Recruiting
- Conditions
- in this study the bioequivalence of test and brand of levetiracetam will evaluated..
- Registration Number
- IRCT20200105046010N1
- Lead Sponsor
- Cobel Darou Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health (liver & heart & kidney )
Body mass index (18-25)
Informed consent
Age (18-60 )
Exclusion Criteria
Smoking
A history of cardiovascular disease
A history of Liver & Kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC, LC-MS/MS or UPLC-MS/MS.
- Secondary Outcome Measures
Name Time Method