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

NCT06193187 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-01-05

No results posted yet for this study

Summary

To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg

Test (T)

DRUG

Entresto 50 mg

Reference (R)

Sponsors & Collaborators

  • Dr. Reddy's Laboratories (Thailand) Limited

    lead INDUSTRY

Principal Investigators

  • Assoc. Prof. Somruedee Chatsiricharoenkul, M.D. · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-03-31
Completion
2024-08-31

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 NCT06193187 on ClinicalTrials.gov