This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group 1: Single-dose of Ranolazine 500 mg tablet of the test drug manufactured by Tadbirkalayejam pharmaceutical Company , in the first period. Cross-over design with one
Sponsors
Tadbir Kala Jam
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age between 18 - 55 Informed consent form Body mass index range (18-30)
Exclusion criteria
Exclusion criteria: Smoking Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy Having cardiovascular and renal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the drug in blood. Timepoint: 0, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 8, 12, 24, 48 h 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: ?????? ???? ??? ??? ????? ???? -????. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMassoud Amanlou
Tehran University of Medical Sciences
Outcome results
None listed