This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablet Opsumit 10 mg manufactured by Actelion as a reference product. after the washout period, the volunteers receive Macitentan 10 mg tablet
Sponsors
Alborz Zagros 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 Macitentan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma. Timepoint: 0, 1, 2, 3, 4, 5, 5.5, 6 , 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 24, 48, 72, h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration is recorded.;Extent of drug 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