This study involves healthy volunteers and examines two formulations of a medication that combines sacubitril and valsartan. The medications being tested are film-coated tablets containing 97 mg of sacubitril and 103 mg of valsartan. One formulation is a test product called Sacubitrilo/valsartán Normon, and the other is a reference product called Entresto. Both medications are taken by mouth and contain the same active substances in the same amounts.
The purpose of the study is to compare how the body absorbs and processes the test formulation compared to the reference formulation and to show that they work in a similar way in the body. This type of study is called a bioequivalence study, which means researchers want to demonstrate that the two formulations behave similarly when taken by healthy volunteers.
The study follows a crossover design, which means that participants will receive both formulations at different times with a break between doses. Volunteers will take a single dose of each medication under fasting conditions, meaning they will not have eaten before taking the tablets. Blood samples will be collected to measure the levels of sacubitril and valsartan in the body over time. This allows researchers to compare how quickly and how much of each active substance enters the bloodstream with each formulation.
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