Could a single pill replace two for high blood pressure?
NCT ID NCT07486453
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests whether a new single pill containing three blood pressure medicines works the same as taking two separate pills. The trial involves 60 healthy adults who will take both versions at different times to compare how their bodies absorb the drugs. The goal is to see if the combination pill is a safe and effective alternative for treating high blood pressure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sacubitril, alisartan, and amlodipine (a combination pill for high blood pressure)
- What this could lead to
- If successful, this could lead to a simpler, single-pill treatment for high blood pressure, making it easier for patients to take their medication.
- What could go wrong
- This is a very early Phase 1 study in healthy people, not patients. It only checks if the body processes the drugs similarly, not if they work better. The results may not apply to people with high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088, China
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