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Can a generic match the original heart failure drug?

NCT ID NCT07746908

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This trial checks whether a generic version of the heart failure drug sacubitril/valsartan (called Valsatril) is absorbed by the body the same way as the brand-name drug Entresto. Sixty healthy adults will take a single dose of each tablet under fasting conditions, with a break in between. Researchers will measure drug levels in the blood to see if the two versions are bioequivalent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacubitril/Valsartan (as Valsatril or Entresto tablets)
What this could lead to
If the generic matches the brand-name drug, it could offer a more affordable treatment option for heart failure.
What could go wrong
This is an early-phase study in healthy volunteers, so results may not reflect real-world use in patients. The generic must prove it is absorbed the same way.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Feb 2025

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 * Healthy volunteers aged 18 to 55 years inclusive. * Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive). * Subjects who are healthy as determined by routine physical examination, including vital sign monitoring and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis). * Subjects should have negative urine test for drugs of abuse and alcohol breath analysis at screening and prior to each check-in. * All subjects should be free from any epidemic or contagious diseases (e.g., Malaria, Dengue, Covid-19) * Subjects agreed to sign the Informed Consent Form * Subjects agreed not to consume grapefruit and/or its products within 14 days prior to the start of study. * Subjects agreed to discontinue Vitamin, dietary supplements and herbal products 14 days prior to the first dose of study medication. Exclusion Criteria: * Inability to take oral medication * History of smoking (≤3 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological /connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.. * Known hypersensitivity to any xenobiotic and Sacubitril/Valsartan or any of the excipients. * A prior history of angioedema due to an ACEI or ARB. * Subject received any of the investigational drug within four weeks. * Subjects with salt imbalance in the blood (especially high levels of potassium in the blood). * Donation or loss of more than 400 mL of blood within 3 months prior to the screening. * Ingestion of OTC drug, within 07 days of drug administration. * History of intake of any prescribed medicine during a period of 14 days, prior to drug administration * Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2). * Subject with history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Sacubitril /Valsartan to the subjects.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center for Bioequivalence Studies and Clinical Research (CBSCR) , ICCBS, University of Karachi

    Karachi, Sindh, 75270, Pakistan

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