In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..
Conditions
Interventions
Intervention 1: Intervention group: INDOCIN Hard GelatinCapsules 25 mg manufactured by ZYLA LIFE SCIENCES as a reference. Intervention 2: Intervention group: Indomethacin Hard Gelatin Capsules 25 mg
Sponsors
Tehran darou
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: En 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, 0.5, 1, 1.5 , 2 , 2.5 , 3 , 3.5 , 4 4.5 , 5 , 5.5 , 6 , 7, 8 , 9 , 10 , 12 & 24h after drug administration. 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