This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult study participants.
This study is a single-center, randomized, open-label, single oral dose, two-formulation, two-sequence, four-period, fully replicated crossover bioequivalence study designed to compare the bioequivalence of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The medication sequence for sequence A is as follows: in the first and third cycles, the test formulation (T: Sacubitril Alesartan Amlodipine Tablets) is taken; in the second and fourth cycles, the reference formulation (R: Sacubitril Alesartan Calcium Tablets + Benazepril Amlodipine Tablets) is taken.The administration date should be at least 14 days apart each time.
The administration sequence for sequence B is as follows: in the first and third cycles, the reference formulation (R: sacubitril amlasiatin calcium tablet + benazepril hydrochloride tablet) is administered; in the second and fourth cycles, the test formulation (T: sacubitril amlasiatin and hydrochloride tablet) is administered; each administration date is at least 14 days apart.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine
Time frame: through study completion,an average of 47days
AUC0-t of EXP3174、Sacubitril、LBQ657
Time frame: through study completion,an average of 47days
AUC0-∞of EXP3174、Sacubitril、LBQ657
Time frame: through study completion,an average of 47days
AUC0-72h of Amlodipine
Time frame: From 0 o'clock to 72 hours
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