Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets

March 18, 2026 updated by: Shenzhen Salubris Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230088
        • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Study participants aged 18 to 60 years (inclusive of 18 and 60 years), both male and female
  • Body weight not less than 50 kg. Body Mass Index (BMI) = weight (kg) / height^2 (m^2). BMI must be within the range of 19 to 26 kg/m^2 (inclusive of the limit values)
  • The study participant is able to communicate well with the research staff, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign a written informed consent form
  • The study participant or their partner has no plans for pregnancy, sperm donation, or egg donation during the study period and for 3 months after drug administration, and must agree to use at least one acceptable effective contraceptive method
  • During the screening period: 110 mmHg ≤ seated systolic blood pressure (SBP) < 140 mmHg, 65 mmHg ≤ seated diastolic blood pressure (DBP) < 90 mmHg, and no orthostatic hypotension.

Exclusion Criteria:

  • Those who smoked more than 5 cigarettes per day on average in the 3 months prior to the trial and are unable to quit smoking during the trial period.
  • Pregnant or breastfeeding women, or female study participants of childbearing potential with a positive blood pregnancy screening.
  • Known allergic reaction to angiotensin II receptor antagonists (such as sacubitril/valsartan sodium, alisartan ester, losartan, valsartan) and calcium channel blockers (such as nifedipine, amlodipine), or their excipients; or allergic constitution (multiple drug and food allergies).
  • Alcoholics or those who frequently consumed alcohol within the 3 months prior to screening, i.e., consuming more than 14 standard alcohol units per week (1 unit alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or those with a positive alcohol breath test, or those unable to stop using any alcohol-containing products during the trial period.
  • Those who donated blood or experienced significant blood loss (>400 mL), used blood products, or received a blood transfusion within the three months prior to screening.
  • Those who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period, or subjects with a history of surgery affecting drug absorption, distribution, metabolism, or excretion.
  • Those who have been vaccinated within 3 months prior to screening.
  • History of hypotension, syncope, needle fainting, swallowing difficulties, any gastrointestinal disease affecting drug absorption, or any history of conditions increasing hemorrhagic risk, such as acute gastritis or gastroduodenal ulcers.
  • Use of any drug that alters hepatic enzyme (CYP3A4) activity or inhibitors of transporters (OAT1/3, OATP1B1/3) within 28 days prior to screening.
  • Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days prior to screening.
  • Participation in any drug clinical trial and administration of any other investigational drug, or use of investigational products, within 3 months prior to taking the study drug.
  • Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram (ECG), or laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation profile, and four infectious disease markers) at screening.
  • Any other disease or medical history considered by the investigator as unsuitable for participation in this study, such as disorders of the central nervous, cardiovascular, digestive, respiratory, urinary, hematopoietic, immune systems, psychiatric conditions, or metabolic abnormalities.
  • Consumption of chocolate, any caffeine-containing, or xanthine-rich foods or beverages within 48 hours prior to taking the study drug.
  • History of drug abuse or substance abuse, or a positive urine drug screen at screening.
  • Those with special dietary habits who cannot comply with the unified dietary requirements, or those with lactose intolerance (e.g., history of diarrhea after drinking milk).
  • Any other reason considered by the investigator as unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A T-R-T-R
The first period and the third period: Sacubitril Alisartan Amlodipine Tablets 240mg/5mg；The second period and the fourth period：Sacubitril Allisartan Calcium Tablets 240mg+Amlodipine Besylate Tablets 5mg
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.
Other: Sequence B R-T-R-T
The first period and the third period: Sacubitril Allisartan Calcium Tablets 240mg+Amlodipine Besylate Tablets 5mg；The second period and the fourth period： Sacubitril Alisartan Amlodipine Tablets 240mg/5mg
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine
Time Frame: through study completion，an average of 47days
through study completion，an average of 47days
AUC0-t of EXP3174、Sacubitril、LBQ657
Time Frame: through study completion，an average of 47days
through study completion，an average of 47days
AUC0-∞of EXP3174、Sacubitril、LBQ657
Time Frame: through study completion，an average of 47days
through study completion，an average of 47days
AUC0-72h of Amlodipine
Time Frame: From 0 o'clock to 72 hours
From 0 o'clock to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Salubris Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAL0130A102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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