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IRCT20200513047423N5 IRCT 2021-11-29 Fatak chemie pars Pharmacy Bioequivalance study of Famotidine 40 mg Bioequivalance study of Famotidine 40 mg tablets manufactured by Fatak Chemie pars pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with famotidine tablets manufactured by Ratiopharm. 2021-11-05 anticipated 24 Complete https://irct.ir/trial/54067 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 https://kitset.ir/numbers/random#random-number-form. These first 12 random numbers create the 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 Bioequivalance Famotidine 40 mg. Intervention 1: Intervention group 1: One Famotidine 40 mg tablet manufactured by Fatak chemie pars company (Test drug) is administrated to each of 12 healthy volunteer of group 1. Intervention 2: Intervention group 2: One Famotidine 40 mg tablets manufactured by Ratiopharm German company is administrated to each o 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 bioequivalance report. When: The results of bioequivalance study of Famotidine tablets will be shared after accepting by Iranian food and drug organization. To whom: The results of bioequivalance study of Famotidine 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 farmed laboratory How to obtain: To complied of educational filed of eager to result of investigation. Comments:
public Dr Amir mehdizahed
Apart 14, No. 65, Razi Ave, Enqhelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 A_mehdizadeh@gmail.com Ofoqh pharmed labratory scientific Dr setareh Akbari
No.65, Razi Ave, Enghelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 8862 2578 a_mehdizade@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Healthy liver Healthy kidney Volunteers should not be too fat or too thin and their weight index should be in the appropriate range 18 years 50 years Both Out of age ranges smoking pragnancy Behavior Behavior Intervention group 1: One Famotidine 40 mg tablet manufactured by Fatak chemie pars company (Test drug) is administrated to each of 12 healthy volunteer of group 1. Intervention group 2: One Famotidine 40 mg tablets manufactured by Ratiopharm German company is administrated to each o 12 healthy volunteers of group 2. Plasma concentration changing after administration of Famotidine tablet.Plasma concentration of famotidine at Tmax reaches about 200 ng/mL and its measurement range is from 10ng / mL to 700ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Famotidine is between 1 and 3 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of famotidine. High performance liquid chromatography is used to determine the concentration of famotidine in plasma. Fatak chemie pars Approved 2021-10-05 Ethics committee of Iran University of Medical Sciences Apart 14, No. 65, Razi St., Enqelab Ave. Tehran Tehran Iran (Islamic Republic of)