This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral Elvanse 70 mg capsule as a reference product. after washout period, the volunteers received Lisdexamfetamine 70 mg capsule manufactured by ta
Sponsors
Tadbir Kala Jam
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-55years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Lisdexamfetamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 6 h 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