Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator - Trial NCT06233201
Access comprehensive clinical trial information for NCT06233201 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 34 participants.
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Study Focus
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product
Interventional
drug
Sponsor & Location
Bio-innova Co., Ltd
Timeline & Enrollment
Phase 1
Jun 04, 2024
Jul 28, 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 randomized,
 open-label, single dose, two way crossover design with two-period, two-treatment and
 two-sequence under fed condition and at least 7 days washout period between the doses.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06233201
Non-Device Trial