This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: single dose of Empagliflozin/Metformin 25/1000 mg tablet of the test drug manufactured by Actoverco pharmacutical company , in the first period. Cross-over design w
Sponsors
Actoverco Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General health (liver, heart, kidney) of volunteers Informed consent form Body mass index range (18-30) Age between18-55
Exclusion criteria
Exclusion criteria: Smoking Having a history of cardiovascular disease Having a history of liver & kidney disease Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the drug in blood. Timepoint: 0, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 7.5, 8, 10, 12 ,24 ,48h after drug. Method of measurement: Liquid Chromatography with Mass-Mass Detector. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the device analysis of the samples and through the WinNonLine software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMassoud Amanlou
Tehran University of Medical Sciences
Outcome results
None listed