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NCT06248112

Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets

A Bioequivalence Study of Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets in Healthy Thai Volunteers Under Fasting Condition
Bio-innova Co., Ltd·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
Sacubitril and Valsartan-Test product
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bio-innova Co., Ltd
Timeline & enrollment
Phase
Phase 1
Start date
May 06, 2024
End date
Jul 06, 2024
Enrollment
40 participants
Primary outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t),Maximal measured plasma concentration (Cmax)

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that
 of a reference for mulation when given as equal labeled dose. The study will be a randomized,
 open-label, single oral dose, full replicated crossover design with four-period,
 two-treatment, and two-sequence under fasting condition and at least 14 days washout period
 between the doses.

ICD-10 classifications
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06248112
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06248112 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bio-innova Co., Ltd and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 40 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.