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IRCT20111107008022N5 IRCT 2019-03-15 Kushan Pharmed Company Bioequivalency study of two different Metformin formulations Comparative bioequivalence study of two different Metformin 750mg formulations (Koushan pharmed & reference) in 24 Iranian volunteers 2018-12-21 anticipated 24 Complete https://irct.ir/trial/35126 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: In the first period, the test and the reference drug are randomly divided into two groups of 12 (group A and B), then in the second period, in the cross over form, the groups A and B will be received reference and test drug, Blinding description: In this study, the volunteers, according to the predetermined random table that is available to the researcher, are in one of the groups receiving the test and reference drug. To blind the analyst and volunteers, the information collected from the drug concentration in the plasma of them is encoded and will be unlocked the codes after completion of the analysis. Bioequivalence Health and normal volunteers. Intervention 1: Intervention group: Single dose of Metformin 750 mg tablet manufactured by Koushan Pharmed Pharmaceutical company in 24 healthy volunteers. Intervention 2: Intervention group: Single dose of Glucophage 750 mg tablet manufactured by Merck Pharmaceutical company in 24 healthy volunteers. Yes - There is a plan to make this available What will be shared: The pharmacokinetic data obtained from the study are for each volunteer in both the test and reference groups. When: 6 months after the end of the study To whom: All researchers and clinical specialists Conditions: There is no denial of access to data Where to obtain: The results of the project are reported in the form of a published paper How to obtain: If results are published in online articles, there will be no problem accessing the results Comments:
public Dr.Katayoun Derakhshandeh
Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1590 k.derakhshandeh@umsha.ac.ir Hamedan University of Medical Sciences scientific Katayoun Derakhshandeh
Faculty of Pharmacy , Hamadan University of Medical Sciences, Shaheed Fahmideh Blvd., In front of Mardom Park, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1590 k.derakhshandeh@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 24 healthy male and female volunteers will participate in this study. Aged 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW Exclusion criteria: Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment 20 years 45 years Both -- -- Treatment - Drugs Treatment - Drugs Intervention group: Single dose of Metformin 750 mg tablet manufactured by Koushan Pharmed Pharmaceutical company in 24 healthy volunteers Intervention group: Single dose of Glucophage 750 mg tablet manufactured by Merck Pharmaceutical company in 24 healthy volunteers Drug plasma concentration. Timepoint: blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h following drug administration. Method of measurement: Using HPLC instrument. Pharmacokinetic parameters. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0; 12.0; 16.0; 20.0; 24.0; 30.0 and 36 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models. Kushan Pharmed Company Approved 2018-10-12 Ethics committees of Hamadan University of Medical Sciences School of Pharmacy, Hamadan University of Medical Sciences, Beside Mardom amusement Park, Shahid Fahmideh Blvd, Hamadan , Iran Hamadan Hamadan Iran (Islamic Republic of)