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IRCT20130626013776N20 IRCT 2020-03-28 AryaTinaGene Biopharmaceutical Co Bioequivalence Study of Somatropin in Healthy Human Volunteers Study of the pharmacokinetic and pharmacodynamic and safety properties of Somatin® (5 mg/1.5 ml cartridges, AryaTinaGene Biopharmaceutical Co) in comparison to Norditropin® (5 mg/1.5 ml cartridges, Novo Nordisk) in healthy volunteers 2020-04-20 anticipated 30 Complete https://irct.ir/trial/46583 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: Each subject is identified by a number from 1 to 30. 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 8 1 R/T Reference Test 2 T/R Test Reference 3 T/R Test Reference 4 R/T Reference Test 5 T/R Test Reference 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 R/T Reference Test 12 R/T Reference Test 13 T/R Test Reference 14 T/R Test Reference 15 T/R Test Reference 16 R/T Reference Test 17 T/R Test Reference 18 R/T Reference Test 19 R/T Reference Test 20 R/T Reference Test 21 T/R Test Reference 22 T/R Test Reference 23 R/T Reference Test 24 R/T Reference Test 25 R/T Reference Test 26 R/T Reference Test 27 T/R Test Reference 28 T/R Test Reference 29 T/T Test Reference 30 R/T Reference Test. Bioequivalence .. Intervention 1: Intervention group: A subcutaneous injection of a single dose of 5 mg of Somatin produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers. Intervention 2: Intervention group: A subcutaneous injection of a single dose of 5 mg of Norditropin produced by Novo Nordisk Co. 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) 4934174515 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences scientific Hossein Amini
Sari Road, Km 2
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Volunteers, 18-50 years of age. The subject is able and willing to provide signed 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 Both History of allergy or sensitivity to somatropin. 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 the present study. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study. Treatment - Drugs Treatment - Drugs Intervention group: A subcutaneous injection of a single dose of 5 mg of Somatin produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers Intervention group: A subcutaneous injection of a single dose of 5 mg of Norditropin produced by Novo Nordisk Co. to healthy volunteers. Serum concentration of somatropin, IGF-1 and IGFBP-3. Timepoint: −1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection. Method of measurement: Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay. Area under serum concentration-time curve. Timepoint: −1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection. Method of measurement: Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay. Time to reach maximum serum concentration. Timepoint: Sampling at times of 1, 2, 3, 4 and 6 hours after injection. Method of measurement: From serum concentration-time curve. Serum half-life. Timepoint: From the terminal 84 hours of serum concentration-time profile. Method of measurement: Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay. AryaTinaGene Biopharmaceutical Co Approved 2020-03-09 Ethics Committee of Golestan University of Medical Sciences Falsafi Building, Sari Road Km 2 Gorgan Golestan Iran (Islamic Republic of)