This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral Pirfenex 200 mg tablet manufactured by CIPLA LTD company as a reference product. after washout period, the volunteers received Pirfenidone 200
Sponsors
?Actoverco Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-55 years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Pirfenidone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0-0.25-0.5-1-1.5-2-2.5-3-4-5-6-8-10-12-24 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMassoud Amanlou
Tehran University of Medical Sciences
Outcome results
None listed