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NCT06266988

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

A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
Viatris Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chronic Heart Failure
Drug/Device/Intervention
Sacubitril and Valsartan Tablets 97mg/103mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Viatris Inc.
Timeline & enrollment
Phase
Phase 1
Start date
Mar 01, 2024
End date
Aug 01, 2024
Enrollment
48 participants
Primary outcome

Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software),Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software)

Summary

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

ICD-10 classifications
Heart failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureHypertensive heart disease without (congestive) heart failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06266988
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06266988 through Pure Global AI's free database. This Phase 1 trial is sponsored by Viatris Inc. and is currently Not yet recruiting. The study focuses on Chronic Heart Failure. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.