In-vivo Bioequivalence Test of Pirfenidone tablet 200 mg Arang Pharma with brand drug (PIRFENEX® 200mg, Cipla, India)
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N61
- Lead Sponsor
- Arang Pharm 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 Plasma drug concentration. Timepoint: Sampling times in this study will be 0? 0.5? 0.75 ?1.33? 1? 1.66? 2? 2.5? 3? 3.5? 4? 5? 6? 8? 12 ? 24 2 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method