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A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions - Trial NCT06266988

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.

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NCT06266988
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06266988
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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

Study Focus

Chronic Heart Failure

Sacubitril and Valsartan Tablets 97mg/103mg

Interventional

drug

Sponsor & Location

Viatris Inc.

Timeline & Enrollment

Phase 1

Mar 01, 2024

Aug 01, 2024

48 participants

Primary Outcome

Bioequivalence based on Cmax period (using the validated Phoenixยฎ WinNonlinยฎ software),Bioequivalence based on AUC period (using the validated Phoenixยฎ WinNonlinยฎ software)

Summary

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

ICD-10 Classifications

Heart failure
Heart failure, unspecified
Congestive heart failure
Hypertensive heart disease with (congestive) heart failure
Hypertensive heart disease without (congestive) heart failure

Data Source

ClinicalTrials.gov

NCT06266988

Non-Device Trial