Bioequivalence Study of Valsatril Tablet Versus Entresto® (Sacubitril/Valsartan 24/26mg) 24mg/26mg Tablet.
brief summary
This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.
detailed description
This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations.
A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design.
Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.
official title
An Open Label, Two Treatments, Single Dose, Cross Over, Bioequivalence Study of Valsatril Tablet of SAMI Pharmaceuticals (Pvt) Ltd Versus Entresto® Tablet of Novartis Pharmaceuticals Ltd., Under Fasting Condition in Adult Healthy Subjects.