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 Metformin ER. 750 mg FC. Tablets. Intervention 2: Control group: Single-dose of the reference drug GLUCOPHAGE® ER. 750 mg. Merck Seron
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: 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 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