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 Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company. Intervention 2: Control group: Single-dose of the reference drug M
Sponsors
Tadbir Kala Jam
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age (18-55years old) General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent
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 |
|---|---|
| Drug plasma concentration. Timepoint: 0 , 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 5 , 6 , 8 , 10 , 12 , 24 , 48h after drug administration. Method of measurement: Liquid chromatography–mass spectrometry. | — |
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 ContactMohammad Ali Karkhaneh Yousefi
Tadbir Kalaye Jam co.
Outcome results
None listed