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IRCT20200407046981N16 IRCT 2021-09-14 Daana pharmaceutical company Study of absorption and elimination rate of Atorvastatin 40 mg tablets in comparison with standard tablets of Atorvastatin (Lipitor®). Randomized, single-dose, crossover comparative bioequivalence study of the Atorvastatin 40 mg tablets produced by Daana pharmaceutical Co versus Lipitor® (Pfizer company) in 24 healthy males under fasting conditions 2021-10-02 anticipated 24 Complete https://irct.ir/trial/57227 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: First, a table of random numbers from 1 to 24 is created. The table numbers are assigned to individuals in the order in which the candidates enter the list on the day of the experiment, and the candidates in two groups with numbers 1-12 and numbers 13-24 will receive reference and test medicine, respectively. Bioequivalence Bioequivalence study. Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are placed in the Intervention group 2. In fact, every single volunteers is used as control for himself. Intervention 2: Intervention group 2: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablets (Lipitor), produced by Pfizer Company (Brand). After the washout period, the volunteers are placed in the Intervention group 1. In fact, every single volunteers is used as control for himself. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr Hamed Hamishehkar
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3336 7914 Hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Dr Jaber Emami
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7111 Emami@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The weight limit for each volunteer is between 60 and 100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. 18 years 60 years Male Known hypersensitivity or idiosyncratic reaction to Atorvastatin or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing. Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are placed in the Intervention group 2. In fact, every single volunteers is used as control for himself. Intervention group 2: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablets (Lipitor), produced by Pfizer Company (Brand). After the washout period, the volunteers are placed in the Intervention group 1. In fact, every single volunteers is used as control for himself. Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 and48 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS). AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 6، 8، 10، 12، 24 and 48 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. Daana pharmaceutical company Approved 2021-08-02 Ethics committee of Tabriz University of Medical Science Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)