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IRCT20200513047423N2 IRCT 2021-10-07 Sina Pishgam Darou Novin Bioequivalance study of Omeprazole 20mg Bioequivalance study of Omeprazole 20mg capsules manufactured by Sina Pishgam Darou Novin pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Omprazole capsules manufactured by Hexal 2021-10-08 anticipated 24 Complete https://irct.ir/trial/59007 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 firs 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 Omeprazole 20mg. Intervention 1: Intervention group: OneOmeprazple capsule 20mg manufactured by Sina Pishgam Darou Novin (Test drug) is administrated to each of 12 healthy volunteers of group 1. Intervention 2: Intervention group: One Omeprazole 20mg capsule manufactured by HEXAL company 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 bioequivalance report. When: The results of bioequivalance study of Omeprazole capsules will be shared after accepting by Iranian food and drug organization. To whom: The results of bioequivalance study of Omeprazole capsules will be shared 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 laboratory How to obtain: To complide of educational filed of eager to result of investigation. Comments:
public Dr Amir mehdizadeh
No.65, Razi Ave, Enghelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 a_mehdizadeh@gmail.com Ofogh pharmed laboratory scientific Dr Farzad kobarfard
No.64, Razi Ave, Enghelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 a_mehdizadeh@gmail.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 group: OneOmeprazple capsule 20mg manufactured by Sina Pishgam Darou Novin (Test drug) is administrated to each of 12 healthy volunteers of group 1. Intervention group: One Omeprazole 20mg capsule manufactured by HEXAL company is administrated to each of 12 healthy volunteers of group 2. Increasing plasma concentration after administration of Omeprazple capsules 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 Omeprazole is between 1.5 and 2 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. Method of measurement: In this study, the variable is plasma concentration of Omeprazole. High performance liquid chromatography is used to determine the concentration of Omeprazole in plasma. Sina Pishgam Darou Novin Approved 2021-09-19 Ethics committee of school and Nurcing & midwiferi-shahid beheshti univercity of medica No.65, Razi Ave, Enghelab Ave Tehran Tehran Iran (Islamic Republic of)