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Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets

NCT06248112 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-08

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be a randomized, open-label, single oral dose, full replicated crossover design with four-period, two-treatment, and two-sequence under fasting condition and at least 14 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Sacubitril and Valsartan-Test product

Test-Product: Sacubitril 97 mg and Valsartan 103 mg film-coated tablets Manufactured by: Hetero Labs Ltd., India

DRUG

Sacubitril and Valsartan-Reference product

Reference-product: ENTRESTOTM (Film-Coated Tablets) 97/103 mg Manufactured by: Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd., Singapore for Novartis Pharma AG, Basle, Switzerland

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2024-06-22
Completion
2024-07-06

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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 NCT06248112 on ClinicalTrials.gov