Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets - Trial NCT06248112
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.
Study Focus
Sponsor & Location
Bio-innova Co., Ltd
Timeline & Enrollment
Phase 1
May 06, 2024
Jul 06, 2024
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
Data Source
ClinicalTrials.gov
NCT06248112
Non-Device Trial