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

NCT06922253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-04-10

No results posted yet for this study

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

Interventions

DRUG

Sacubitril and Valsartan-Test product

1 tablet of 97 mg Sacubitril / 103 mg Valsartan

DRUG

Sacubitril and Valsartan-Reference product

1 tablet of 97 mg Sacubitril / 103 mg Valsartan

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-28
Primary Completion
2025-01-20
Completion
2025-03-17

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922253 on ClinicalTrials.gov