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IRCT2016033021315N4 IRCT 2017-06-06 AryoGen Pharmed Company Comparison between AltebrelTM and Enbrel® A randomised, double-blind, single-dose, active-controlled, crossover study in healthy subjects to demonstrate pharmacokinetic equivalence of AltebrelTM (produced by AryoGen Pharmed) and Enbrel:registered:(produced by Amgen Company) 2016-12-04 anticipated 34 Complete https://irct.ir/trial/18711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. 1 rheumatoid arhtritis. Intervention 1: a prefilled syringe dose of AltebrelTM (25 mg/0.5mL) to be administered as a single subcutaneous injection. Intervention 2: a prefilled syringe dose of Enbrel® (25 mg/0.51mL) to be administered as a single subcutaneous injection.
public Somayeh Amini
no 2, Emad khorassani D.D, Derakhti St, Dadman Blvd, Shahrake Gharb
Tehran Iran (Islamic Republic of) 1468813112 +98 21 4347 3210 Amini.s@orchidpharmed.com Orchid Pharmed Company scientific Ahmadreza Jamshidi
Rheumatology Research Center, Doctor Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0065 jamshida@sina.tums.ac.ir Rheumatology Research Center, Doctor Shariati Hospital Iran (Islamic Republic of) Inclusion: 1)Provide written IC to participate in the trial and to comply with the trial procedures. 2)Take written informed consent to participate in the trial and to abide by the trial restrictions. 3)Be healthy male between the ages of 18 and 55 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests. 4)Have a body mass index between 20.0 and 30 kg/m², inclusive 5)Have Chest X-ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist. Exclusion: 1.Being doubtful about their availability to complete the trial. 2.history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IMP formulation or comparable drugs. 3.Active or latent Tuberculosis or who have a history of Tuberculosis. 4.history of invasive systemic fungal infections or other opportunistic infections 5.systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process 6.serious infection associated with hospitalisation and/or which required intravenous antibiotics 7.history of and/or current cardiac disease 8.Have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit. 9.Intake medication with a half-life > 24 h within 1 month or 5 half-lives of the medication prior to the first administration of IMP. 10.Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody. A positive test for HIV antibody. 11.History of CNS demyelinating disorders in family (MS) 12.Have a history of smoking >10 cigarettes per day 18 years 55 years Male M05, M06.9 Seropositive rheumatoid arthritis, Rheumatoid arthritis, unspecified Treatment - Drugs Treatment - Drugs a prefilled syringe dose of AltebrelTM (25 mg/0.5mL) to be administered as a single subcutaneous injection a prefilled syringe dose of Enbrel® (25 mg/0.51mL) to be administered as a single subcutaneous injection Cmax of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: ELISA. AUC infinite of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: Calculation. AUClast of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation. Tmax of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation. T½ of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation. Volume of distribution (VD) of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation. Clearance (CL) of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation. Adverse events (AE). Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: physical Examination. AryoGen Pharmed Company Approved 2017-04-18 Tehran University of medical science District 6, Poursina St. Tehran Iran (Islamic Republic of)