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IRCT20200513047423N7 IRCT 2022-04-06 Shahrdaru Pharmaceutical Co. Bioequivalance study of Tramadole 100 mg Tablets Bioequivalance study of Tramadole 100 mg Tablets manufactured by Shahr Daru pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Reference Tablets 2022-05-27 anticipated 24 Complete https://irct.ir/trial/62365 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 Tramadole 100 mg. Intervention group: One Tramadole 100 mg tablet manufactured by Shahr daru company (Test drug) is administrated to each of 12 healthy volunteer of group 1. 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 Tramadole tablets will be shared after accepting by Iranian food and drug organization. To whom: The results of bioequivalence study of Tramadole 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 ,Enghelab Ave.
Tehran Central African Republic 1133713144 +98 21 6673 8727 Ofoghfarmed.lab@gmail.com Ofoqh pharmed labratory scientific Dr Farzad kobarfard
Tehran
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 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 pregnancy Behavior Intervention group: One Tramadole 100 mg tablet manufactured by Shahr daru company (Test drug) is administrated to each of 12 healthy volunteer of group 1 Plasma concentration changing after administration of Tramadole 100 mg tablet.Plasma concentration of Tramadole at Tmax reaches about 350 ng/mL and its measurement range is from 10ng / mL to 1000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Tramadole is between 1 and 2 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 Tramadole. High performance liquid chromatography is used to determine the concentration of Tramadole in plasma. Shahrdaru Pharmaceutical Co. Approved 2022-02-22 Ethics committee of school and Nurcing & midwiferi-shahid beheshti univercity of medical No.65, Razi Ave, Enghelab Ave Tehran Tehran Iran (Islamic Republic of)