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IRCT20210519051345N13 IRCT 2022-08-15 Tabriz University of Medical Sciences Investigating the in vivo bioequivalence of Azithromycin 250 mg capsule In vivo bioequivalence study of Azithromycin 250 mg capsule manufactured by Ani Darman Co. compared with Zithromax® 2022-09-11 anticipated 24 Complete https://irct.ir/trial/65256 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 placed in group A and numbers 13-24 will be placed in group B. Group A will receive intervention 1 (test product) and group B will receive intervention 2 (innovator product), and after the first period, the interventions of both groups will change for the second period. Bioequivalence In the present study, ‌in vivo bioequivalence of Azithromycin 250 mg capsules (Ani Darman Co.) compared to Zithromax®. Intervention 1: Intervention group: Intervention group will receive a single test drug product. Blood samples will be collected for 72 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography equipped 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 72 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 further information.
public Parvin Zakeri-Milani
Faculty of Pharmacy, University of Medical Sciences, 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
Faculty of Pharmacy, University of Medical Sciences, 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) General Health (in terms of Liver, Heart and Kidney) 18 years 59 years Both Smoking, History of cardiovascular disease, liver disease and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy Treatment - Drugs Treatment - Drugs Intervention group: Intervention group will receive a single test drug product. Blood samples will be collected for 72 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography equipped with mass spectroscopy detector Control group: Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 72 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 concentration of drug. Timepoint: 0.5-72 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography). Ani Darman Pharmaceutical Company Approved 2022-08-01 Biomedical Research Committe, Tabriz University of Medical Sciences No.2 Central Building 3rd Floor, University of Medical Sciences, Daneshgah st. Tabriz East Azarbaijan Iran (Islamic Republic of)