Study of bioequivalence of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) and foreign samples on 24 healthy Iranian volunteers.
Not Applicable
Recruiting
- Conditions
- In this study the bioequivalence of test and brand of Staperkin will be evaluated..
- Registration Number
- IRCT20200105046010N9
- Lead Sponsor
- Tabriz University of Medical Sciences
- 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 (18-28 )
Informed consent
Age (18-60 )
Exclusion Criteria
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma drug concentration. Timepoint: Hour. Method of measurement: Blood sampling.
- Secondary Outcome Measures
Name Time Method