This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group 1: single dose, one oral tablet of Madopar 250mg manufactured by Merck, as a reference product. Intervention 2: Intervention group 2:Single dose, one oral tablet of
Sponsors
Ronak Pharm company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to Levodopa or Benserazide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentration of the drug. Timepoint: Pre-dose, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: The 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 ContactElham Ghasemian
Islamic Azad University
Outcome results
None listed