Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)

NCT06922253 | Completed Phase 1

• 1 other identifier: 24-VIN-0563
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in healthy, adult, human subjects under fasting condition.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  If the intra-subject CV of the reference formulation for Cmax is less than or equal to 30%, the conventional acceptance range of 80.00% - 125.00% for bioequivalence will be applied to Cmax.

  48.00 hours

• Area Under the Curve from time zero to time of last measurable concentration (AUC0-t)

  For, AUC0-t, acceptance range for bioequivalence is 80.00 - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R).

  48.00 hours

Secondary Outcomes (4)

• Area Under the Curve from time zero to time infinite (AUC0-∞)

  48.00 hours

• Time to reach peak plasma concentration (Tmax)

  48.00 hours

• Plasma Elimination Half-Life (t1/2)

  48.00 hours

• The elimination rate constant (Kel)

  48.00 hours

Study Arms (2)

Sacubitril and Valsartan Tablets

EXPERIMENTAL

Sacubitril and Valsartan 97 mg / 103 mg Tablets

Drug: Sacubitril and Valsartan-Test product

Entresto® (Sacubitril and Valsartan) Tablets

EXPERIMENTAL

Entresto® (Sacubitril and Valsartan) 97 mg / 103 mg Tablets

Drug: Sacubitril and Valsartan-Reference product

Interventions

Sacubitril and Valsartan-Test product DRUG

1 tablet of 97 mg Sacubitril / 103 mg Valsartan

Sacubitril and Valsartan Tablets

Sacubitril and Valsartan-Reference product DRUG

1 tablet of 97 mg Sacubitril / 103 mg Valsartan

Entresto® (Sacubitril and Valsartan) Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged between 18 and 45 years (both inclusive).
• Subjects' weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with minimum of 45 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
• Subject with Creatinine Clearance ≥80 ml/min.
• Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
• Subjects having clinically acceptable chest X-Ray (PA view), if taken.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative urine alcohol test / breath alcohol test.
• Non-smokers.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• For male Subjects:
• Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to refrain from donating sperm during the study period
• \- For Female Subjects: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
• Subjects having negative urine pregnancy test at screening and negative serum β-hCG pregnancy test on admission day of period 01 (only for female subjects).
• Female Subjects who are non-pregnant and non-lactating.

You may not qualify if:

• Subjects having hypersensitivity to Sacubitril and Valsartan or related class of drugs or any of its excipients or heparin.
• Subject with the serum potassium level \>5.4 mmol/l during screening.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
• Subjects who undergone any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
• History or presence of alcoholism or drug abuse.
• History or presence of asthma, urticaria or other significant allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• History or presence of cancer or basal or squamous cell carcinoma.
• Subject having difficulty with donating blood.
• Subjects having difficulty in swallowing solid dosage form like tablets or capsules.
• Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
• Subject having major illness within past 03 months.
• Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
• Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Veeda Clinical Research Ltd.

Ahmedabad, Gujarat, 380 051, India

Location

MeSH Terms

Interventions

sacubitril

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: December 28, 2024
• Primary Completion: January 20, 2025
• Study Completion: March 17, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)