Bioequivalence study of Teriflunomide 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions
Not Applicable
Not yet recruiting
- Conditions
- Immunomodulatory drug for the treatment of Multiple Sclerosis (MS).
- Registration Number
- IRCT20200407046981N1
- Lead Sponsor
- Zahravi pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 14
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.