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IRCT20230629058615N1 IRCT 2023-09-24 Behshad Daroo Company bioequivalence study Bioequivalence study of 100 mg doxycycline delayed-release capsules manufactured by Behshad Daroo company with reference product manufactured by Avet (Heritage) 2023-10-07 anticipated 24 Complete https://irct.ir/trial/72710 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, 24 volunteers will be divided into two groups. The first group will receive the brand medication, and the second group will receive the generic medication. The Grouping will be done in a randomized manner: In this study, 24 medication, including 12 generic medication and 12 brand medication, will be randomly assigned to patients using a random code (including numbers and letters). After coding the drugs, each code will be randomly assigned to an individual using a random command. Due to the crossover design of the study, in the second period, each patient will receive the other type of drug, Blinding description: In this study, patients will not be informed about the type of drug they are receiving. Bioequivalence The study will be performed on healthy volunteers.. Intervention 1: Intervention group: Receiving Iranian generic medicine in the first week and receiving brand medicine in the second week. Intervention 2: Intervention group: receiving the brand medication in the first week and Iranian generic medication in the second week. Yes - There is a plan to make this available What will be shared: Blood concentrations of received medication by individuals and the exact protocol of drug administration When: After publishing the article related to the study To whom: The main person responsible for similar studies Conditions: designing similar studies Where to obtain: Islamic Azad university How to obtain: Application registration in the administrative department of the university Comments:
public Farshad Hashemian
Tehran, Gholhak, Dr. Shariati St., Yakhchal St., School of Pharmacy.
tehran Iran (Islamic Republic of) 1941933111 22640599 fhashemian@gmail.com Islamic Azad University scientific Amir
Shahid Hemet highway , Shahid Kabiri Tameh St. (Shahin North) at the end of Shahid Basarati St., School of Pharmacy
Tehran Iran (Islamic Republic of) 1475886671 44606181 rezazadeh.am@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Volunteer’s health (based on the results of physical examinations and clinical tests) Volunteer’s health (based on the results of physical examinations and clinical tests) Body mass index of 18.5-30 kg/m2 No history of allergy to tetracycline antibiotics and excipients used in the products formulations No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study No history of diseases affecting the pharmacokinetic processes of the drug No history of smoking, alcohol and narcotics use Not being pregnant or breastfeeding Adherence to study criteria based on ethical commitment and informed consent Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2) 18 years 40 years Both Pregnancy Tobacco or alcohol use, acute or chronic Failure to obtain any of the mentioned items regarding health tests Drug administration before and during the study Lack of adherence to study criteria Incidence of adverse reactions liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2) Other Other Intervention group: Receiving Iranian generic medicine in the first week and receiving brand medicine in the second week Intervention group: receiving the brand medication in the first week and Iranian generic medication in the second week C max- Tmax- AUC0-t. Timepoint: 0 - 0.5 - 1 -1.5 - 2 - 2.5 - 3 - 3.5 - 4 -4.5 - 6 - 8 - 10 to 12 - 24 -48 -72 Hours after drug administration. Method of measurement: Drug analysis will be performed using a high-performance liquid chromatography (HPLC) equipped with a UV detector. Behshad Daroo Company Approved 2022-03-10 Ethics committee of Faculty of pharmacy and pharmaceutical sciences, Tehran Medical Sciences, Islami Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)