Bioequivalence study of Dimethyl fumarate capsule manufactured by Zistdaru danesh company (Teczifuma 240mg) in Iranian healthy volunteers
Not Applicable
Recruiting
- Conditions
- In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Dimethyl Fumarate capsule of test and reference in healthy volunteers..
- Registration Number
- IRCT20200623047902N1
- Lead Sponsor
- Zistdaru danesh Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart and Kidney), Body Mass Index (18-28), Conscious Consciousness, Age (18-60)
Exclusion Criteria
Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of concentration of active form of drug in bood. Timepoint: After taking blood sample. Method of measurement: HPLC-MASS MASS.
- Secondary Outcome Measures
Name Time Method