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IRCT20200105046010N33 IRCT 2021-06-21 Razak Pharma In-vivo Bioequivalence Test of Atorvastatin® tablet with brand drugs (LIPITOR® 100mg, Pfizer, Germany). In- Vivo Bioequivalence study of Atorvastatin tablet 40 mg Razak Pharma. with brand drug (LIPITOR® 40mg, Pfizer, Germany) in Iranian healthy volunteers. 2021-05-15 anticipated 24 Complete https://irct.ir/trial/55611 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Blinding description: Candidates are not aware of the test drug or brand name. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Atorvastatin and Atorvastatin are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form. Bioequivalence In this study, the disease is not examined. Subject bioequivalence test and reference tablets Atorvastatin studied.. Intervention 1: Intervention group: Intervention group received one test drug table(Atorvastatin tablet 40 mg Razak Pharma ). Intervention 2: Control group: Control group received one reference drug table(Atorvastatin tablet 40 mg LIPITOR® Pfizer, Germany). 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 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 - Other Treatment - Other Intervention group: Intervention group received one test drug table(Atorvastatin tablet 40 mg Razak Pharma ). Control group: Control group received one reference drug table(Atorvastatin tablet 40 mg LIPITOR® Pfizer, Germany). 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. Razak Pharma 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)