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IRCT20110523006565N2 IRCT 2022-02-05 Kermanshah University of Medical Sciences Bioequivalence Study of Ursodeoxycholic acid Bioequivalence Study of Ursodeoxycholic acid Tablets manufactured by Raihaneh and So-Se-Pharm Pharmaceutical companies 2022-02-10 anticipated 24 Complete https://irct.ir/trial/61639 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Blinding description: All the subjects will be received one tablet from either test or reference preparations on two working days separated by a wash-out period of two weeks. Bioequivalence Condition 1: Bioequivalence. Condition 2: Bioequivalence. Intervention group: Prescription of ursodesoxycholic acid ,300 mg Tablet manufactured by Reihaneh pharmaceutical company from Iran in the first week. 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 plan to publish the results
public Gholamreza Bahrami
Medical Biology Research Center, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6714415185 +98 83 3428 1562 gbahrami@kums.ac.ir Kermanshah University of Medical Sciences scientific Gholamreza Bahrami
Medical Biology Research Center, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6714415185 +98 83 3428 1562 gbahrami@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Written informed consent. Normal findings in the physical examination. Clinical laboratory values within 10% above or below the laboratory’s stated normal range To be a non-smoker 18 years 45 years Both History of hypersensitivity to the study drug or related products Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of common medications Any clinically significant illness during the 4 weeks prior to day 1 of this study Maintenance therapy with any drug, or history of drug dependence, alcohol abuse, or serious neurological or psychological disease Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study HIV and Hepatitis A, B and C positive subjects Treatment - Drugs Intervention group: Prescription of ursodesoxycholic acid ,300 mg Tablet manufactured by Reihaneh pharmaceutical company from Iran in the first week Plasma concentration. Timepoint: 0 , 0.5, 1, 1.5 , 2, 2.5, 3, 3.5, 4, 5 , 6 , 8 , 10, 24 , 48 , 72. Method of measurement: Lc-mass mass. Reihaneh Pharmaceutical Company Approved 2021-10-11 Ethical committe of Kermanshah University of Medical Sciences and Health Services Beheshti blv, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)