In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Macitentan 10 mg of test and reference in healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group 1: Macitentan 10 mg tablet produced by Nano Fanavaran Darouyi Alvand Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of thi
Sponsors
Nano Fanavaran Darouyi Alvand pharmaceutical Co
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy male subjects in the age range of 18-60 years with BMI (Body Mass Index) of 18.5-30. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. Candidates who have consented to the informed consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Macitentan or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1? 2? 4? 5? 5.5? 6? 6.5? 7? 7.5? 8? 8.5? 9? 9.5? 10 ?12? 24? 36 ? 48 and 72 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1? 2? 4? 5? 5.5? 6? 6.5? 7? 7.5? 8? 8.5? 9? 9.5? 10 ?12? 24? 36 ? 48 and 72 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed