A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions

NCT06266988 | Not Yet Recruiting Phase 1

• 1 other identifier: SCVL-TFZ-1010
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective is to is to evaluate the bioequivalence of two formulations

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software)

  According to bioequivalence criteria, the 90% CI of the geometric mean ratio of Cmax should lie within 80.00-125.00%.

  Upto 48 hours post-dose in each treatment

• Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software)

  According to bioequivalence criteria, the 90% CI of the geometric mean ratio of AUC should lie within 80.00-125.00%.

  Upto 48 hours post-dose in each treatment

Study Arms (2)

Test Product

EXPERIMENTAL

Sacubitril and Valsartan Tablets 97mg/103mg to be orally administered

Drug: Sacubitril and Valsartan Tablets 97mg/103mg

Reference product

ACTIVE COMPARATOR

Entresto® (97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex) to be orally administered

Drug: Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)

Interventions

Sacubitril and Valsartan Tablets 97mg/103mg DRUG

Each Tablet contains 97 mg of Sacubitril and 103 mg of Valsartan

Also known as: Sacubitril and Valsartan Tablets

Test Product

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

Each Tablet contains 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex

Also known as: Entresto

Reference product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Thai Male/Female must be 18-55 years of age, body weight \>50.0 kg with body mass index (BMI) = 18.0-30.0 kg/m2, inclusive.
• Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 100 or not over 139 mmHg, diastolic blood pressure not lower than 70 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
• Screening ECG without clinically significant abnormalities
• Screening visit laboratory values of blood test including hematology (CBC with differential), FBS (Fasting Blood sugar), BUN (Blood urea Nitrogen), Cr, and liver function test (AST (Aspartate transaminase), ALT (Alanine transaminase) , total bilirubin and ALP (Alkaline phosphatase)) must be within the normal range or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
• Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
• Must have serum HBsAg, anti-HCV and anti-HIV negative
• Female subject must have serum β-hCG negative.
• Subject willing to avoid or follow precautions while driving, operating machinery and while working on high elevations.
• Female subject of childbearing potential or male subject agrees to use an acceptable birth control method from screening visit to the followup visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow-up visit. Hormonal contraceptives are not acceptable.
• Female subject of non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))
• Female subject must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing at Period 1, Period 2, Period 3 and Period 4.
• Non-smoker (never smoked or no smoking within the previous 1 year)
• Subject willing to not participate in blood donations (≥500 mL) until 56 days after completion of the study (last subject visit) and willing to not participate in clinical research studies until 30 days after completion of the study (last subject visit).
• Refrain from using herbal medications, cannabis containing products, dietary supplements (e.g., St. John's Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of Period 4.
• Subject must have ended any systemic medications or any medications that have any impact on gastrointestinal system at least 30 days prior to Day 1 or at least 5 times of elimination half-life prior to Day 1 and agree to continue their refraining throughout the follow-up period.

You may not qualify if:

• Known hypersensitivity to sacubitril or valsartan or any other similar class of drugs or its components
• Past medical history of renal and hepatic insufficiency
• Subject has a history of any illness that, in the opinion of Principal/Clinical Investigator or designated physicians, might confound the result of the study or pose an additional risk in administering investigational product to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
• History of hereditary or idiopathic angioedema
• Have a history of angioedema related to previous ACE inhibitor or ARB therapy
• Have history of drug abuse (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
• Have positive result of urine drug abuse testing on opioids (Mor, MTD), cannabinoids (THC), Meth, Coc or MDMA at screening visit or before dose administration at each period
• Alcohol abuse or excessive use (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
• Have positive result of alcohol breathing test at screening visit or before dose administration at each period
• Female subject is pregnant or breast feeding.
• Difficulties fasting or consuming standard meals
• Difficulties swallowing whole tablets
• Donation or loss of whole blood:
• ≥50 mL and ≤499 mL within 30 days prior to Day 1
• ≥500 mL within 56 days prior to Day 1

Sponsors & Collaborators

• Viatris Inc.: lead

MeSH Terms

Interventions

sacubitril; Valsartan; sacubitril and valsartan sodium hydrate drug combination

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Ariya Khunvichai, Ph.D

  Medica Innova Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Arun Kumar, M.Pharm

CONTACT

967630054; akumar@viatris.com

Venkatesh Daggumati, M.Pharm

CONTACT

7032185444; Venkatesh.Daggumati@viatris.com

Study Design

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

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share