This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group 1: single dose, one oral tablet (EBETREX® 2.5 mg, Ebewe. Austria) as a reference product. after one week washout period, the volunteers received Methotrexate 2.5 mg
Sponsors
Nanoalvand Pharmaceutical Co
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 Hypersensitivity to the drug Pregnancy Alcohol & Drug addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24,48 h after drug administration. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. | — |
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 by liquid chromatography with mass spectroscopy detector.;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