clinical trial · NCT06266988
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Chronic Heart FailureSacubitril and Valsartan Tablets 97mg/103mgEntresto (Sacubitril and Valsartan Tablets 97mg/103mg)
brief summary
Primary objective is to is to evaluate the bioequivalence of two formulations
started
Mar 1, 2024
primary completion
Apr 1, 2024
completion
Aug 1, 2024
last updated
Feb 20, 2024
detailed description
The objectives of this study is to evaluate the bioequivalence of two formulations of sacubitril/valsartan 97 mg/103 mg film coated tablets, Entresto® (Reference) and Sacubitril and Valsartan Tablets 97mg/103mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions and secondarily to examine the pharmacokinetics and safety of sacubitril, sacubitrilat and valsartan in healthy Thai subjects under fasting conditions
official title
A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
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