Primary HypertensionPhase 1NCT07486453
Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
A Phase 1 study testing Sequence A T-R-T-R and Sequence B R-T-R-T in people with Primary Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Sequence A T-R-T-R and Sequence B R-T-R-T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 25 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088
About this study
Official title: 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.
Read the 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
- Being tested
- Sequence A T-R-T-R, Sequence B R-T-R-T
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence A T-R-T-RDrug
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.
Sequence B R-T-R-TDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A T-R-T-R | Experimental | 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 Receives: Drug: Sequence A T-R-T-R |
| Sequence B R-T-R-T | Other | 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 Receives: Drug: Sequence B R-T-R-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine
Measured: through study completion，an average of 47days
AUC0-t of EXP3174、Sacubitril、LBQ657
Measured: through study completion，an average of 47days
AUC0-∞of EXP3174、Sacubitril、LBQ657
Measured: through study completion，an average of 47days
AUC0-72h of Amlodipine
Measured: From 0 o'clock to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486453
- Sponsor's protocol ID
- SAL0130A102
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets Versus Sacubitril Alisartan Calcium Tablets Combined With Amlodipine Besylate Tablets
- ClinicalTrials.gov ID
- NCT07486453
- Acronym / sponsor ID
- SAL0130A102
- Conditions
- Primary Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A T-R-T-R | Experimental | Drug: Sequence A T-R-T-RThe 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 |
| Sequence B R-T-R-T | Other | Drug: Sequence B R-T-R-TThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequence A T-R-T-RThe 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 A T-R-T-R |
| Sequence B R-T-R-TThe 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. | Drug | Sequence B R-T-R-T |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sequence A T-R-T-R and Sequence B R-T-R-T in people with Primary Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, Professor (13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine (time frame: through study completion，an average of 47days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.