Healthy Volunteers Clinical Trial
Official title:
A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 24 mg/26 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions.
This study will be an open label, single dose, randomized, two-formulation, four-period, two-sequence, fully replicate crossover study. In this study, 48 healthy subjects will be randomized into two cohorts to receive a single dose of sacubitril and valsartan 24 mg/26 mg film-coated tablets for 48 hours and will be separated by a washout period of 7 days. This study will be conducted at one clinical site. ;
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