In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..
Conditions
Interventions
Intervention 1: Intervention group: Single-dose of the test drug MEZALON® 500 mg Supp, Burayhan Pharma, IRAN. Intervention 2: Control group: Single-dose of the reference drug ASACOL® 500 mg Supp, Till
Sponsors
Aburayhan Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-30) Informed consent Age(18-55)
Exclusion criteria
Exclusion criteria: Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 0? 1? 2? 3? 3.5? 4? 4.5? 5? 5? 6? 6.5? 7? 8? 10? 24 , 48h after drug adminstration. Method of measurement: HPLC-MS/MS. | — |
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 ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed