Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule - Trial NCT06233227
Access comprehensive clinical trial information for NCT06233227 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 28 participants.
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Study Focus
Sponsor & Location
Bio-innova Co., Ltd
Timeline & Enrollment
Phase 1
Sep 24, 2024
Dec 16, 2024
Primary Outcome
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product,Maximal measured plasma concentration (Cmax) of dutasteride test product and reference product
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 randomized,
 open-label, single dose, two way crossover design with two-period, two-treatment and
 two-sequence under fasting condition and at least 28 days washout period between the doses.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06233227
Non-Device Trial