IRCT20170717035129N1 IRCT 2021-02-11 Hakim Pharmaceutical Company Bioequivalence of Valsartan tablets Single-dose bioequivalence studies of Valsartan tablets (160 mg) in healthy volunteers 2021-02-12 anticipated 26 Complete https://irct.ir/trial/54224 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: In order to randomize, in this study, random allocation rule has been used. For this purpose, first a total sample size of the candidates who met the inclusion criteria was determined and then randomly assigned a number of 13 of them to the first group who use the test drug using the table of numbers. We assign the other 13 persons to the second group who receive the reference medicine. Then, in the second period, the group that received the test drug will receive the reference drug and the other group will receive the test drug, Blinding description: Candidates receive medication twice. Once Iranian product (generic) and once the foreign product (reference). The volunteers and the study physician do not know what product they received each time. Because the medicine is taken out of its box and blister and given to the volunteers, they will have no information about the type of medicine. Bioequivalence Healthy subjects. Intervention 1: Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 160 mg Valsartan tablets made by Hakim Company during a treatment period. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by HPLC. Intervention 2: Control group: Receiving reference medicine: In this group, each volunteer receives one reference tablet of 160 mg valsartan in a course of treatment. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by HPLC. 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 This study has been done for the decision of the Ministry of Health regarding the entry of the drug into the market, and the results will be published at the discretion of the Ministry of Health.