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IRCT20200407046981N1 IRCT 2020-04-18 Zahravi pharmaceutical company 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 Randomized, single-dose, crossover comparative bioequivalence study of Teriflunomide (Trigio®) 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions 2020-05-21 anticipated 14 Complete https://irct.ir/trial/47145 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Each subject is identified by a number from 1 to 14. This number is allocated according to their entrance to volunteers' list in the screening day. Then, the following randomization table is used according to the crossover design of the study. All participants randomized into two sequences of Test/Reference and Reference/Test products Subjects Dosing Sequence Day 1 Day 22. 1 R/T Reference Test 2 R/T Reference Test 3 R/T Reference Test 4 R/T Reference Test 5 R/T Reference Test 6 R/T Reference Test 7 R/T Reference Test 8 T/R Test Reference 9 T/R Test Reference 10 T/R Test Reference 11 T/R Test Reference 12 T/R Test Reference 13 T/R Test Reference 14 T/R Test Reference. Bioequivalence Immunomodulatory drug for the treatment of Multiple Sclerosis (MS). 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 this product. Intervention 2: Intervention group (Reference): Teriflunomide 14 mg tablets (Aubagio®), produced by Sanofi Genzime Company is the reference product. In each period, 7 of 14 subjects will be given single oral dose of this product. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Hamed Hamishehkar
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3336 7914 Hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Jaber Emami
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 3792 7111 Emami@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 16 years 60 years Male 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 Treatment - Drugs Treatment - Drugs 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 this product. Intervention group (Reference): Teriflunomide 14 mg tablets (Aubagio®), produced by Sanofi Genzime Company is the reference product. In each period, 7 of 14 subjects will be given single oral dose of this product. 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. 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. Zahravi pharmaceutical company Approved 2020-03-16 Iran National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)