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Bioequivalence Study of Valsatril Tablet Versus Entresto® Sacubitril/Valsartan 24/26 mg Tablet.

NCT07746908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-10

No results posted yet for this study

Summary

This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.

Conditions

  • Healthy Participants

Interventions

DRUG

Valsatril®

(Sacubitril/Valsartan) 24 mg/26 mg tablet of SAMI Pharmaceuticals (Pvt) Ltd

DRUG

Entresto®

Entresto® (Sacubitril/Valsartan) 24 mg/26 mg tablet of Novartis Pharmaceuticals Ltd

Sponsors & Collaborators

  • SAMI Pharmaceuticals (Pvt.) Ltd.

    collaborator INDUSTRY

  • Center for Bioequivalence Studies and Clinical Research

    lead OTHER

Principal Investigators

  • Dr. M. Raza Shah · Center for Bioequivalence Studies and Clinical Research

  • Dr. Naghma Hashmi · Center for Bioequivalence Studies and Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2025-07-18
Completion
2025-07-18

Countries

  • Pakistan

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 NCT07746908 on ClinicalTrials.gov