In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..
Conditions
Interventions
Intervention 1: Intervention grorug up: Single-dose of the test drug Mefenamic Acid500-mg Capsules manufactured by pharma shimi Company in the first period. Intervention 2: Control group: Single-dose
Sponsors
Pharma Shimi
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 A history of cardiovascular disease A 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 , 0.5 , 1.0 , 1.5 , 2.0 , 2.5 , 3.0 , 3.5 , 4.0 , 5.0 , 6.0 , 8.0 , 10.0 , 12.0 , 24 h 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