Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Fingolimod 0.5-mg capsule produced by Zahravi Co. (Domestic). In each period, 12 of 24 subjects will be
Sponsors
Zahravi pharmaceutical company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: The weight limit of each volunteer should be between 60 and 100 kg. All volunteers must be non-smokers. 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 consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Fingolimod 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. Taking any medicine during two weeks before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 before dosing? 1? 2? 4? 6? 8 ?10 ? 11? 12? 13? 14? 24 ? 48 and 72 hours 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? 6? 8 ?10 ? 11? 12? 13? 14? 24 ? 48 and 72 hours 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