IRCT20220209053979N2 IRCT 2022-07-07 Alborz Darou A bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition 2022-06-30 anticipated 24 Complete https://irct.ir/trial/63559 observational Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Blinding description: Since both Alborz Daru and the reference tablets are manufactured in the same size and white color , it is possible to make blinded.The drug (test drug or reference drug) is packed in small disposable containers a day before the study, Therefore, the volunteer does not know which drug he is taking. Each volunteer is also assigned a code that the analyzer does not know which drug the volunteer received in each phase of the study. Bioequivalence Blood concentration of test and reference drug is compared. Intervention 1: Intervention group: Oral administration of a single dose of 1 tablet of losartan H 50/12.5 mg of Alborz Darou to 12 healthy volunteers under fasting condition with 240 ml water, then 15 blood samples are taken from each volunteer at specified times. In the second phase,this group will received the losartan H 50/12.5 mg of Merck and 15 blood samples are taken from them. Intervention 2: Intervention group: Oral administration of a single dose of 1 tablet of losartan H 50/12.5 mg of Merck to 12 healthy volunteers under fasting condition with 240 ml water, then 15 blood samples are taken from each volunteer at specified times. In the second phase,this group will received the losartan H 50/12.5 mg of Alborz Darou and 15 blood samples are taken from them. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study is confidential and it is not possible to publish the data without the permission of the manufacturer