Bioequivalence Study of Valsatril Tablet Versus Entresto® Sacubitril/Valsartan 24/26 mg Tablet.

This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations.

A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design.

Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.

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.