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NCT06244407

The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT and Reference Product (Galvus Met®) in Healthy Thai Volunteers Under Fed Conditions
International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
International Bio service
Timeline & enrollment
Phase
Phase 1
Start date
May 23, 2024
End date
Jun 02, 2024
Enrollment
40 participants
Primary outcome

Plasma Area Under the Curve (AUC(0 to 36hr)) for Vildagliptin and Metformin

Summary

To determine and compare the rate and extent of absorption of a test formulation with that of
 a reference innovator formulation when given as equal labeled dose in healthy subjects under
 fed conditions

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06244407
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06244407 through Pure Global AI's free database. This Phase 1 trial is sponsored by International Bio service and is currently Not yet recruiting. The study focuses on Healthy Volunteer. 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.