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IRCT20130626013776N6 IRCT 2018-01-21 Raha Pharmaceuticals Bioequivalence study of metformin hydrochloride 1000 mg tablets under fasting conditions A study to compare the relative bioavailability of Raha and Merck formulations of metformin 1000 mg tablets in 24 healthy adult male volunteers under fasting conditions 2017-10-23 anticipated 24 Complete https://irct.ir/trial/28426 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: Table of random numbers was used. Bioequivalence Healthy volunteers. Intervention 1: Intervention group: Single dose of Rahamet (metformin 1000 mg) tablet manufactured by Raha Pharmaceuticals. Intervention 2: Intervention group: Single dose of Glucophage (metformin 1000 mg) tablet manufactured by Merck Pharmaceuticals. Yes - There is a plan to make this available What will be shared: The plasma concentration-time profiles of volunteers and other pharmacokinetic data from brand product could be provided. When: Within 3 months after termination of the study To whom: All academic members could apply for the data. Conditions: These data belong to the principal investigator and could be used only after getting a formal permission from him. Where to obtain: Please send your requests by E-mail How to obtain: The applicant should have scientific eligibility Comments:
public Dr. Hossein Amini
No. 6, Aftabgardan Bulding, Golshahr 14, Golshahr Bolv.
Gorgan Iran (Islamic Republic of) 4916817693 +98 17 3252 5972 haminhplc@yahoo.com Gorgan Bioanalysis Center scientific Dr. Hossein Amini
Sari Road Km2
Goragn Iran (Islamic Republic of) 4916817693 +98 17 3252 5972 haminhplc@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Males, 18-50 years of age (inclusive). The subject is able and willing to provide written informed consent. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. The subject has stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 18 years 45 years Male History of allergy or sensitivity to metformin hydrochloride history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. Presence of gastrointestinal disease or history of malabsorption within the last year. History of psychiatric disorders occurring within the last two years that required hospitalization or medication. Presence of a medical condition requiring regular treatment with prescription drugs. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to dosing. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing. --- --- Treatment - Drugs Treatment - Drugs Intervention group: Single dose of Rahamet (metformin 1000 mg) tablet manufactured by Raha Pharmaceuticals Intervention group: Single dose of Glucophage (metformin 1000 mg) tablet manufactured by Merck Pharmaceuticals Drug plasma concentration. Timepoint: Before intervention and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC. Area under plasma concentration-time curve. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC. Time to reach Cmax. Timepoint: During 4 hours after drug administration. Method of measurement: Blood sampling and drug analysis by HPLC. Gorgan University of Medical Sciences Raha Pharmaceuticals Gorgan University of Medical Sciences Approved 2017-12-25 Ethics Committee of Golestan University of Medical Sciences Gorgan, Shast cola road, Falsafi Building Gorgan Golestan Iran (Islamic Republic of)