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IRCT20220111053692N13 IRCT 2023-07-03 Kimiara Heram Pharmaceutical Company Bioequivalence study of Ibuprofen ER 800 mg Bioequivalence study of Tablet Ibuprofen ER 800 mg kimiara Heram pharmaceutical company versus Brufen® Retard Abbott/UK pharmaceutical company Tablet after single oral dosing in healthy volunteers 2023-07-02 anticipated 24 Complete https://irct.ir/trial/71000 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: In order to randomly allocate people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are placed in random order. After entering the study, each candidate will take an envelope, numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 (test product) and group B will receive intervention 2 (reference product) and after the first period, the interventions of the two groups will be moved for the second period, Blinding description: This study is a Double-blind (participant) clinical trial. Ibuprofen and Brufen® tablets are removed from the package by the administrator and placed in similar and coded cans. Bioequivalence Bioequivalence study of Tablet Ibuprofen ER 800 mg (kimiara) versus Brufen® Retard (Abbott/UK pharmaceuticals) Tablet after single oral dosing in healthy volunteers. Intervention 1: Intervention group: Receives one tablet of test drug (Ibuprofen ER 800 mg kimiara Heram Pharmaceutical Company). Blood samples were taken from the volunteers for 48 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector. Intervention 2: Control group: Receives one reference medicine tablet (Brufen® Retard 800 Abbott/UK corporation). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Bardia Jamali
Unit 1,No. 1,Crot Building, Jahan mehr Street,Shahid Gomnam Street,Fatemi Square
Tehran Iran (Islamic Republic of) 1431653941 +98 21 8897 4707 info@tampouya.com Tam Pouya Consulting & Research Company scientific Bardia Jamali
Unit 1,No. 1,Crot Building, Jahan mehr Street,Shahid Gomnam Street,Fatemi Square
Tehran Iran (Islamic Republic of) 1431653941 +98 21 8897 4707 info@tampouya.com Tam Pouya Consulting & Research Company Iran (Islamic Republic of) 18 to 55 years old Weight in range of 10 % proper body weight All volunteers should be in a good health condition on the basis of medical history ,physical examination , routine blood test. Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV. Gender: male 18 years 55 years Male Any history of allergy to the drug or formulation components Those with known history of drug abuse. alcohol consumer or cigarette smokers. Taking medications that have drug interactions with Ibuprofen until one month before studying. Disinclination to take the test Blood donation or blood loss of more than 200 ml in the past month Other Other Intervention group: Receives one tablet of test drug (Ibuprofen ER 800 mg kimiara Heram Pharmaceutical Company). Blood samples were taken from the volunteers for 48 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector. Control group: Receives one reference medicine tablet (Brufen® Retard 800 Abbott/UK corporation). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector Drug concentration in plasma samples. Timepoint: In times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours after the start of the intervention. Method of measurement: chromatography. Kimiara Heram Pharmaceutical Company Approved 2023-06-28 Ethics Committees of The Institute of Pharmaceutical Sciences,Tehran University of Medical Sciences Research Institute of Pharmaceutical Sciences, second floor of the old building, Faculty of Pharmacy, Enqelab Square, 16 Azar St. Tehran Tehran Iran (Islamic Republic of)