NCT07486453

Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets

Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets Versus Sacubitril Alisartan Calcium Tablets Combined With Amlodipine Besylate Tablets

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Hypertension

Interventions

Type	Name	Description
DRUG	Sequence A T-R-T-R	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.
DRUG	Sequence B R-T-R-T	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.

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-04-25
• Completion: 2026-04-25
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: China