This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablets Tivicay 50 mg as a reference product. after washout period, the volunteers received Dolutegravir 50 mg for Tadbir Kalaye jam pharmaceu
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 Dolutegravir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 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