In-vivo Bioequivalence Test of Mesalasine 500 mg EC tablet Faran shimi Pharma with brand drug (Asacol® 400 mg ER. Tablets. ?Tillotts Pharma AG, Switzerland)
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N63
- Lead Sponsor
- Pharan shimi Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health
Body mass index between18-28
Informed consent
Being at the age of 18-60 years old
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: Sampling times in this study will be 0? 1? 2? 3?4? 6? 6.5? 7? 7.5? 8? 9? 10? 10.5? 11? 12 ? 24 ,48 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method