Bioequivalence study of Pirfenidone 267mg
Not Applicable
- Conditions
- This study is performed on healthy volunteers..
- Registration Number
- IRCT20200623047902N3
- Lead Sponsor
- Zistdaru Danesh Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-60)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Pregnancy
Alcoholism and Narcoticism
History of allergy to Pirfenidone
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of concentration of drug in bood. Timepoint: before, 0.5 h, 45 min, 1h, 80min, 100min, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h , 12h and 24h after drug consumption. Method of measurement: HPLC-MASS MASS.
- Secondary Outcome Measures
Name Time Method Time to reach maximum concentration. Timepoint: 0.5h, 45min, 1h, 80min, 100min, 2h, 2.5h, 3h, 3.5h, and 4 h after drug consumption. Method of measurement: Observe drug concentrations at different times.;Area under curve. Timepoint: After determining the amount of drug. Method of measurement: Calculation.