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IRCT20200105046010N26 IRCT 2021-03-12 SOBHAN ONCOLOGY Pharmaceutical Lenalidomide cap. 25mg Sobhan Oncology (LENASOB® 25mg), In-Vivo Bioequivalence in iranian healthy volunteer. In- Vivo Bioequivalence study of Lenalidomide cap. 25mg Sobhan Oncology (LENASOB® 25mg) with brand drug (REVLIMID® 25mg Colgene, Bristol-Myers Squibb) in Iranian healthy volunteers 2021-03-15 anticipated 24 Complete https://irct.ir/trial/54953 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: People in different age groups are invited to cooperate through the advertisement.Then people are selected. Individuals will be randomly selected through advertisements. The number of individuals will be randomly selected and the first twelve will be selected as the first sequence and the second twelve will be selected as the second sequence, Blinding description: Candidates are not aware of the test drug or brand name. Bioequivalence In this study, the disease is not examined. Subject bioequivalence test and reference tablets Teriflunomide studied.. Intervention 1: Intervention group: Intervention group received one test drug table(Lenalidomide cap. 25mg Sobhan Oncology Pharma). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of LENASOB in blood samples was measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: Control group received one test drug cap. (REVLIMID® 25 mg Colgene, Bristol-Myers Squibb). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of REVLIMID in blood samples was measured by liquid chromatography with mass spectroscopy detector. No - There is not a plan to make this available Justification or reason for not sharing IPD is These date are as secure between researcher and related industries
public Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences.
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences scientific Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences.
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-60) 18 years 60 years Both Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug Treatment - Drugs Treatment - Drugs Intervention group: Intervention group received one test drug table(Lenalidomide cap. 25mg Sobhan Oncology Pharma). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of LENASOB in blood samples was measured by liquid chromatography with mass spectroscopy detector. Control group: Control group received one test drug cap. (REVLIMID® 25 mg Colgene, Bristol-Myers Squibb). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of REVLIMID in blood samples was measured by liquid chromatography with mass spectroscopy detector. Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: igh Performance Liquid Chromatography with tandem mass spectroscopy detector. Tabriz University of Medical Sciences Approved 2021-03-01 Ethics Committee, Tabriz University of Medical Sciences Third floor of TUMS (Tabriz University of Medical Sciences) central building, Dneshgah St. Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)