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IRCT20200105046010N39 IRCT 2021-09-12 Mofid Pharmaceutical Co. In-vivo Bioequivalence study of Tadalafil tablet with brand drugs (CIALIS Lilly USA) In- Vivo Bioequivalence study of Tadalafil tablet 5 mg Mofid Pharma with brand drugs (CIALIS® 5 mg, Lilly USA) in Iranian healthy volunteers. 2021-08-05 anticipated 24 Complete https://irct.ir/trial/57774 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, the name of total volunteers (24 people) are written on paper pieces and placed to the bottle after wrapped into the aluminum foils. the papers Withrow from bottle randomly. the first and second 12 names randomly taken from the bottle are considered as group A and group B respectively, Blinding description: Iranian Tadalafil tablets and Tadalafil brand are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test medications. Bioequivalence Bio equivalence test. Intervention 1: Intervention group: will receive one test drug tablet (Tadalafil tablet 5 mg Mofid Pharma Pharmaceuticals). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Tadalafil in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: Control group: will receive one test drug table (CIALIS® 5 mg, Lilly USA Pharmaceuticals). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Tadalafil in blood samples will be measured by liquid chromatography with mass spectroscopy detector. No - There is not a plan to make this available Justification or reason for not sharing IPD is These date are as secure between researcher and related industries
public Javad Shokri
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences scientific Javad Shokri
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) General health Body mass index(18-28) Informed consent Age(18-60) 18 years 60 years Both Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug Treatment - Other Treatment - Other Intervention group: will receive one test drug tablet (Tadalafil tablet 5 mg Mofid Pharma Pharmaceuticals). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Tadalafil in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Control group: Control group: will receive one test drug table (CIALIS® 5 mg, Lilly USA Pharmaceuticals). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Tadalafil in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. Mofid Pharmaceutical Co. Approved 2021-05-17 Ethics Committee, Tabriz University of Medical Sciences Third floor of TUMS (Tabriz University of Medical Sciences) central building, Dneshgah St. Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)