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IRCT20200705048005N1 IRCT 2021-02-09 ChemiDaru Pharmaceutical Company bioequivalence of febuxostat Single-dose bioequivalence studies of two febuxostat tablets in healthy volunteers 2020-03-02 anticipated 26 Complete https://irct.ir/trial/49396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: In order to randomize, in this study, random allocation rule has been used. For this purpose, first a total sample size of the candidates who met the inclusion criteria was determined and then randomly assigned a number of 13 of them to the first group who use the test drug using the table of numbers. We assign the other 13 persons to the second group who receive the reference medicine. Then, in the second period, the group that received the test drug will receive the reference drug and the other group will receive the test drug, Blinding description: The study was performed in two periods. Each subject received either test or reference product in each period. Subjects and the physician did not inform about the administered type of the product in each period. Bioequivalence Healthy subjects. Intervention 1: Receiving test formulation (generic product) In this study, subjects received one febuxostat tablet in each period. In the first period of the study, half of subjects received one 80 mg tablet (product of Chemidaru company). Blood samples were collected during 24-hours after after drug administration. َAt predetermined time (14 time points) 5 mL blood samples were collected. After that drug concentration was analysed by HPLC method. Pharmacokinetic parameters were calculated and compared. Intervention 2: Receiving reference formulation (brand product) In this study, subjects received one febuxostat tablet in each period. In the first period of the study, half of subjects received one brand 80 mg tablet (pUloric). Blood samples were collected during 24-hours after after drug administration. After that drug concentration was analysed by HPLC method. Pharmacokinetic parameters were calculated and compared. No - There is not a plan to make this available Justification or reason for not sharing IPD is the study was performed for marketing the generic form of the drug
public Mahraz Osouli
Niayesh Highway, Valiasr Ave
Tehran Iran (Islamic Republic of) 1996835113 02188200118 (155) mahraz.osouli@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azadeh Haeri
Niayesh Highway, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 6153- 14155 +98 21 8820 0118 a_haeri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Male volunteer Age: 18-50 year Healthyvolunteer 18 years 50 years Male History of liver, kidney and cardiovascular diseases that can affect drug clearance from body Any medication prescribed in the last two weeks - - Treatment - Drugs Treatment - Drugs Receiving test formulation (generic product) In this study, subjects received one febuxostat tablet in each period. In the first period of the study, half of subjects received one 80 mg tablet (product of Chemidaru company). Blood samples were collected during 24-hours after after drug administration. َAt predetermined time (14 time points) 5 mL blood samples were collected. After that drug concentration was analysed by HPLC method. Pharmacokinetic parameters were calculated and compared. Receiving reference formulation (brand product) In this study, subjects received one febuxostat tablet in each period. In the first period of the study, half of subjects received one brand 80 mg tablet (pUloric). Blood samples were collected during 24-hours after after drug administration. After that drug concentration was analysed by HPLC method. Pharmacokinetic parameters were calculated and compared. Plasma drug concentration. Timepoint: 0.25 0.5 0.75 1 2 3 4 6 8 10 12 14 24. Method of measurement: HPLC method. ChemiDaru Pharmaceutical Company Approved 2020-03-02 School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University Niayesh Highway, Valiasr Ave Tehran Tehran Iran (Islamic Republic of)