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NCT06233201

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator

A Bioequivalence Study of Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator in Healthy Thai Volunteers Under Fed Condition.
Bio-innova Co., Ltd·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bio-innova Co., Ltd
Timeline & enrollment
Phase
Phase 1
Start date
Jun 04, 2024
End date
Jul 28, 2024
Enrollment
34 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 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
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
NCT06233201
Type
Non-Device Trial
About this record

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.

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.