Can a generic match the original heart failure drug?
NCT ID NCT07746908
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
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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 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 * 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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Genom att skicka in godkänner du våra Användarvillkor
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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