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IRCT20200513047423N1 IRCT 2020-06-24 Sana Med Bio equivalence study of metformin 500 mg Bio equivalence study of metformin 500 mg tablets manufactured by Sana Med pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Glucophage tablets manufactured by MERCK. 2020-06-15 anticipated 24 Complete https://irct.ir/trial/48347 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: We designate to 24 healthy volunteers one number between 1 and 24 . Extraction of 12 numbers is carried out using random number table available in internet. These first 12 numbers establish first group, Blinding description: The main investigator creates a table using randomization and divides 24 healthy volunteer in 2 groups which only he knows the details of group. Test and reference drugs are packaged in special envelopes that administrator and volunteers are blinded regarding to the kind of drugs. Volunteers, administrator (health care professional) and analyst are blinded regarding to reference and test drugs. Bioequivalence Bioequivalence metformin 500 mg. Intervention 1: Intervention group1: One metformin 500 mg tablet manufactured by Sana Med company (Test drug) is administrated to each of 12 healthy volunteers of group 1 . Intervention 2: Intervention group 2: One Glucophage 500 mg tablet manufactured by ACTOVERCO company under the license of MERCK is administrated to each of 12 healthy volunteers of group 2. Yes - There is a plan to make this available What will be shared: Demography tables of volunteers including group 1 and 2 have been shared in bioequivalence report. When: The results of bioequivalence study of metformin tablets will be shared after accepting by Iranian food and drug organization. To whom: The results of bioequivalence study of metformin tablets will be accessed by expert by Iranian food and drug organization and financial supporter. Conditions: To promotion of result of investigation, the results will be shared with eager. Where to obtain: 1-Iranian food and drug organization 2- Ofogh pharmed research laboratory How to obtain: To complied of educational filed of eager to result of investigation. Comments:
public Dr Amir mehdizadeh
No. 65 , Razi Ave ,Enghelan sq
tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 A_mehdizadeh@yahoo.com Ofoqh pharmed labratory scientific Dr Farzad kobarfard
Apart 14, No. 65, Razi Ave, Enqelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 farzadkf@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Healthy liver Healthy kidney observing BMI 18 years 50 years Both Out of age ranges No smoker unhealthy liver and kidney pregnancy Treatment - Drugs Treatment - Drugs Intervention group1: One metformin 500 mg tablet manufactured by Sana Med company (Test drug) is administrated to each of 12 healthy volunteers of group 1 . Intervention group 2: One Glucophage 500 mg tablet manufactured by ACTOVERCO company under the license of MERCK is administrated to each of 12 healthy volunteers of group 2. Increasing plasma concentration after administration of metformin tablets till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of metformin is between 1.5 and 3 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. As in some articles it is mentioned that Tmax of metformin is around 3 hours so the blood samples should be collected in 24 hours. Method of measurement: In this study, the variable is plasma concentration of metformin. High performance liquid chromatography is used to determine the concentration of metformin in plasma. Sana Med Approved 2020-03-02 Ethics committee of school of pharmacy and Nurcing & midwiferi- shahid beheshti univercity of medica No. 65, Razi Ave, Enghelab Sq tehran Tehran Iran (Islamic Republic of)