Study of absorption and elimination rate of Macitentan 10 mg tablets in comparison with standard tablets of Macitentan (Opsumit®).

Not Applicable

Conditions: 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..

Registration Number: IRCT20200407046981N18

Lead Sponsor: ano Fanavaran Darouyi Alvand pharmaceutical Co

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 24

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.