Immunomodulatory drug for the treatment of Multiple Sclerosis (MS).
Conditions
Interventions
Intervention 1: Intervention group (Test): Teriflunomide 14 mg tablets, produced by Zahravi pharmaceutical Co. is the test product. In each period, 7 of 14 subjects will be given single oral dose of t
Sponsors
Zahravi pharmaceutical company
Eligibility
Sex/Gender
Male
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy subjects with BMI 18.5-30 kg/m2 Not having any abnormal finding in laboratory examination or during physical examination. Not having a history of any significant disease. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Ondansetron or any ingredients. Subjects with BP = 9060 mm/Hg or BP = 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 & 72 hour after dosing. Method of measurement: HPLC. | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. 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