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IRCT20190706044111N27 IRCT 2022-01-12 Amin Pharm. Co. Bioequivalence study of Prazosin 5mg tablet of Amin Pharm Co., IRAN A randomized, open label, single dose, crossover, bioequivalence study of Prazosin 5mg tablet produced by Amin Pharm Co., IRAN in comparison owith MiniPress 5mg tablet produced by Laphal Co. in 24 healthy adult subjects under fasting condition 2022-04-20 anticipated 24 Complete https://irct.ir/trial/61007 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Using the rand command in Excel software, one of the sequences AB (test-reference product) or BA (reference-test product) is randomly assigned to each volunteer at random. Bioequivalence Hypertension. Intervention 1: Intervention group: Prazosin, one 5mg tablet, produced by Amin Pharm Co. (IRAN), single dose. Intervention 2: Control group: MiniPress, one 5mg tablet, produced by Laphal company, single dose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Any publication is under permission of Amin Pharm Co.

public Ladan Tayebi

First floor, No 5, Saeidi Dead-end alley, Palestin Ave.

Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. scientific Ladan Tayebi

First floor, No 5, Saeidi Dead-end alley, Palestin Ave.

Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. Iran (Islamic Republic of) Aged between 18 - 50 years Body weight between 50 – 100 kg Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent 18 years 50 years Both History of the gastro-intestinal tract surgery Subject with a history of blood donation or participation in another clinical trial, within the last two months before the first treatment Subject with a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject with a history of disease leading to using drug within 14 days, or any non-prescription medication within 7 days, before the first treatment. I10 Essential (primary) hypertension Other Other Intervention group: Prazosin, one 5mg tablet, produced by Amin Pharm Co. (IRAN), single dose Control group: MiniPress, one 5mg tablet, produced by Laphal company, single dose. Plasma concentration of prazosin after single dose of 5mg prazosin tablet. Timepoint: at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 & 10.0 hr. after dosing. Method of measurement: High Performance Liquid Chromatography (HPLC). Amin Pharm. Co. Approved 2021-12-12 Ethics committee of Zahedan University of Medical Sciences Zahedan University of Medical Sciences; Dr. Hessabi square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)