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NOT YET RECRUITING
NCT07486453
PHASE1

Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets

Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-09

Completion Date

2026-04-25

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China