This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: Volunteers take Pirfenzi 267 mg capsule, which is manufactured by Zistdaru Danesh Company and contains 267 mg of Pirfenidone, as a test product, as a single oral do
Sponsors
Zistdaru Danesh Company
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart and Kidney) Body Mass Index (18-28) Informed consent Age (18-60)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcoholism and Narcoticism History of allergy to Pirfenidone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Ghasemian
Zistdaru Danesh company
Outcome results
None listed