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IRCT20210519051345N45 IRCT 2024-01-22 Tabriz University of Medical Sciences Investigating the in vivo bioequivalence of Eplerenone 50 mg In vivo fasted state bioequivalence study of Eplerenone 50 mg tablet manufactured by Ronak Co. compared with innovator product 2023-12-06 anticipated 24 Complete https://irct.ir/trial/73942 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: To randomly assign participants in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up 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 and group B will receive intervention 2, and after the first period, the interventions of both groups will change for the second period. Bioequivalence In the present study, the products will be administered to healthy volunteers.. Intervention 1: Intervention group: Intervention group: Intervention group will receive a single oral dose of test product (Eplerenone50 mg tablet of Ronak Co.) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively. Intervention 2: Control group: Control group will receive a single oral dose of reference product (Eplerenone 50 mg tablet of Biogaran Co.) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively. 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 Parvin Zakeri-Milani
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori St., Golgasht 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
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori St., Golgasht 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) General Health (in terms of Liver, Heart and Kidney) 18 years 59 years Male Smoking History of cardiovascular disease, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Intervention group will receive a single oral dose of test product (Eplerenone50 mg tablet of Ronak Co.) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively. Control group: Control group will receive a single oral dose of reference product (Eplerenone 50 mg tablet of Biogaran Co.) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively. Plasma concentration of drug. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography). Ronak Co. Approved 2024-01-14 Biomedical Research Committe, Tabriz University of Medical Sciences No.2 Central Building 3rd Floor, Tabriz University of Medical Sciences, Daneshgah st. Tabriz East Azarbaijan Iran (Islamic Republic of)