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The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions - Trial NCT06244407

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.

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NCT06244407
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06244407
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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 Metยฎ) in Healthy Thai Volunteers Under Fed Conditions

Study Focus

Healthy Volunteer

Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

May 23, 2024

Jun 02, 2024

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 person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06244407

Non-Device Trial