In-vivo Bioequivalence Test of Rosuvastatin tablets with brand drug (CRESTOR® 20mg F.C Tab, AstraZeneca, Belgium)
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N41
- Lead Sponsor
- Kharazmi Pharmaceutical Co
- 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 Blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method