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

NCT06273254 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-22

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence Study

Interventions

DRUG

Sacubitril and Valsartan Tablets 49mg/51mg

Each tablet contains Sacubitril 49 mg and Valsartan 51 mg

DRUG

Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg)

Each tablet contains 48.6 mg sacubitril and 51.4 mg valsartan as sodium salt complex

Sponsors & Collaborators

  • Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Ariya Khunvichai, Ph.D · Medica Innova Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-05-31
Completion
2024-09-30

Countries

  • Thailand

Study Locations

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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 NCT06273254 on ClinicalTrials.gov