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IRCT20210519051345N5 IRCT 2021-10-30 Tabriz University of Medical Sciences Bioequivalence study of Quetiapine 100 mg tablet In vivo bioequivalence study of Quetiapine 100 mg tablet manufactured by Fatak Shimi Co. in comparison to innovator product 2021-11-16 anticipated 24 Complete https://irct.ir/trial/59037 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: "Random number table" will be used. Each volunteer will be assigned a two-digit number. After making the table, we need randomly point to a spot on the table and select the numbers, Blinding description: In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). This means that the product will be given to the volunteers for administration outside the original packaging. Bioequivalence In the present study, no diseases will be examined and products will be administered by healthy volunteers.. Intervention 1: Intervention group: Intervention group will receive one test drug capsule. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector. 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 more information.
public Parvin Zakeri-Milani
Tabriz University of Medical Sciences, Faculty of Pharmacy,, Golgasht st Attar Neishaboori st.
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3334 8801 pzakeri@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Parvin Zakeri-Milani
Tabriz University of Medical Sciences, Faculty of Pharmacy, Golgasht st Attar Neishaboori st.
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3334 8801 pzakeri@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: General Health (Liver, Heart and Kidney) Age (20-60) 20 years 59 years Both Exclusion criteria: Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction history of drug allergy Treatment - Drugs Treatment - Drugs Intervention group: Intervention group will receive one test drug capsule. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Control group: Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Plasma Drug Concentration. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: HPLC. Fatak Shimi Pars Co. Approved 2021-10-04 Biomedical Research Committe, Tabriz University of Medical Sciences Tabriz University of Medical Sciences, No.2 Central Building, 3rd Floor, Daneshgah st. Tabriz East Azarbaijan Iran (Islamic Republic of)