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

Inclusion Criteria:

• 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, clinicalexamination 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 writteninformed 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 acceptablemethod of birth control for the duration of the study as judged by theinvestigator(s), such as intrauterine device (IUD), abstinence, bilateral tuballigation or double barrier contraception, i.e., condom + diaphragm, condom +spermicidal or foam Postmenopausal for at least 1 year, or if less than 1 year, thenfollowing acceptable contraceptive measures as mentioned above

• Subjects having negative urine pregnancy test at screening and negative serum β-hCGpregnancy test on admission day of period 01 (only for female subjects).

• Female Subjects who are non-pregnant and non-lactating.

Exclusion Criteria:

• Subjects having hypersensitivity to Sacubitril and Valsartan or related class ofdrugs 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, urogenitalor psychiatric disease or disorder.

• Subjects who undergone any treatment which could bring about induction or inhibitionof 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, organicintracranial 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 andherbal 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 studywithin past 90 days prior to the first dose of the study drug.

• Consumption of xanthine-containing products, tobacco containing products or alcoholor any alcohol containing products within 48.00 hours prior to admission in period

• Consumption of grapefruit or grapefruit juice containing products within 72.00 hoursprior to admission of period 01.

• Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.

• History or presence of significant easy bruising or bleeding.

• History or presence of significant recent trauma.

• Subjects who have been on an abnormal diet (for whatever reason) during the fourweeks preceding the study.

• Female subjects who are currently breast feeding.