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IRCT20130626013776N7 IRCT 2018-07-09 AryaTinaGene Biopharmaceutical Co Bioequivalence Study of Filgrastim in Healthy Human Volunteers Study of the Pharmacokinetic and Pharmacodynamic and Safety Properties of Tinagrast® (300 µg/0.5 ml Syringes, AryaTinaGene Biopharmaceutical Co) in Comparison to Neupogen® (300 µg/0.5 ml syringes, Amgen) in Healthy Volunteers 2018-04-09 anticipated 24 Complete https://irct.ir/trial/32345 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: Each subject will be identified by a number from 1 to 24. Subjects were randomly allocated into 4 groups. Allocated groups: Group ID Volunteers ID number Sequence 1 1, 4, 6,7, 11&12 R/T 2 2, 3, 5, 8, 9, 10 &13 T/R 3 14, 15, 17, 21&22 T/R 4 16, 18, 19, 20, 23 &24 R/T The dosing regime will be as follows: Subjects Group Sequence Day 1 Day 8 ________________________________________________________________ 1 1 R/T Reference Test 2 2 T/R Test Reference 3 2 T/R Test Reference 4 1 R/T Reference Test 5 2 T/R Test Reference 6 1 R/T Reference Test 7 1 R/T Reference Test 8 2 T/R Test Reference 9 2 T/R Test Reference 10 2 T/R Test Reference 11 1 R/T Reference Test 12 1 R/T Reference Test 13 2 T/R Test Reference 14 3 T/R Test Reference 15 3 T/R Test Reference 16 4 R/T Reference Test 17 3 T/R Test Reference 18 4 R/T Reference Test 19 4 R/T Reference Test 20 4 R/T Reference Test 21 3 T/R Test Reference 22 3 T/R Test Reference 23 4 R/T Reference Test 24 4 R/T Reference Test. Bioequivalence Healthy volunteers. Intervention 1: Intervention group: SC injection of a single dose of 300 mcg of Tinagrast produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers. Intervention 2: Intervention group: SC injection of a single dose of 300 mcg of Neupogen produced by Amgen Inc to healthy volunteers. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data are confidential and need permission from the company
public Hossein Amini
Sari Road, Km 2
Gorgan Iran (Islamic Republic of) 4916817693 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences scientific Hossein Amini
Sari Road, Km 2
Gorgan Iran (Islamic Republic of) 4916817693 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Males, 18-50 years of age. The subject is able and willing to provide written informed consent. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. The subject has stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 18 years 50 years Male History of allergy or sensitivity to filgrastim. history of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. Presence of gastrointestinal disease or history of malabsorption within the last year. History of a medical disorders occurring within the last year that required hospitalization or medication Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to dosing. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing. Treatment - Drugs Treatment - Drugs Intervention group: SC injection of a single dose of 300 mcg of Tinagrast produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers Intervention group: SC injection of a single dose of 300 mcg of Neupogen produced by Amgen Inc to healthy volunteers Serum concentration of filgrastim. Timepoint: Before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h after injection. Method of measurement: ELISA method with special kit. Absolute neutrophil count. Timepoint: Before and at 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 h post-injection. Method of measurement: Cell counter. Time to reach maximum serum concentration. Timepoint: Before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h after injection. Method of measurement: From drug serum concentration-time curve. Time to reach maximum absolute neutrophil count. Timepoint: Before and at 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 h post-injection. Method of measurement: From absolute neutrophilcount-time curve. AryaTinaGene Biopharmaceutical Co Approved 2018-06-17 Ethics Committee of Golestan University of Medical Sciences Gorgan, Shast cola road, Falsafi Building Gorgan Golestan Iran (Islamic Republic of)