In- Vivo Bioequivalence study of Atorvastatin tablets 40 mg Kharazmi Pharma with brand drugs (LIPITOR® 40 mg, Pfizer, Germany) in Iranian healthy volunteers.
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N72
- 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 18-55 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? 0.5? 0.75? 1? 1.5? 2? 2.5? 0?3? 4? 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