Other long term (current) drug therapy. Other long term (current) drug therapy
Conditions
Interventions
Intervention 1: Intervention group 1: Sulfasalazine 500 mg Tablet, produced by Tehran Darou is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Aft
Sponsors
Tehran Darou Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age . Body Mass Index (BMI) within 15% of normal range (kg/m2) 18.5 and 30.
Exclusion criteria
Exclusion criteria: Subjects with known allergy to the products tested. History of specific disease or abnormal values ??in laboratory tests and general clinical examination. Consumption of more than 10 cigarettes per day. Loss of more than 500 ml of blood in less than 7 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 11, 24 and 48 hours after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 11, 24 and 48 hours after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehzad Montaha Sangari
Noor Research & Development Institute
Outcome results
None listed