]>
IRCT20111107008022N7 IRCT 2021-06-26 Reihaneh Pharmaceutical Company Bioequivalency study of two different Metformin formulations Comparative bioequivalence study of two different Metformin 1000mg formulations (Reihaneh Pharmaceutical Company & reference) in 24 Iranian volunteers 2021-06-22 anticipated 24 Complete https://irct.ir/trial/56906 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: Each volunteer is identified by the number 1 to 24. The number assigned to each volunteer is based on the priority of being on the list when screening. Due to the cross-sectional study, 24 participants were assigned to test and reference products (groups A and B), respectively, using the Excel program rand command. Then, in the second stage, groups A and B will receive cross-reference and test drugs crosswise, Blinding description: In this study, 24 volunteers were randomly divided into two groups of 12 test (A) and reference (B) drug recipients by Excel software. In this project, the volunteers, person responsible for blood sampling and analyzer are kept blind. To blind these people, all the information collected is coded to the researcher, and after the analysis is completed, codes will be opened. Bioequivalence Health and normal volunteers. Intervention 1: Intervention group: Single dose of Glucophage 1000 mg tablet manufactured by Merck Pharmaceutical company in 24 healthy volunteers. Intervention 2: Control group: Control group: Single dose of Metformin 1000 mg tablet manufactured by Reihaneh 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. Article will be available after it is published. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir" How to obtain: There will be no problem accessing results when publishing results in online articles. The wait time to access the results will be 3 months after the project is completed. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir". Comments:
public Dr.Katayoun Derakhshandeh
Hamadan
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) 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 consentactual Weight (TBW) in the range of 20% IBW 20 years 45 years Both Subject showed clinically relevant deviations from normal in physical examination Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day Use any medication within 14 days before the first treatment A history of allergic to biguanides Treatment - Drugs Treatment - Drugs Intervention group: Single dose of Glucophage 1000 mg tablet manufactured by Merck Pharmaceutical company in 24 healthy volunteers Control group: Control group: Single dose of Metformin 1000 mg tablet manufactured by Reihaneh 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: Half-life, Cmax The peak plasma concentration of a drug after administration, The volume of distribution, and Clearance. 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. Reihaneh Pharmaceutical Company Approved 2021-06-12 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)