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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. The manufacturer needs to formulate a generic Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT. This study has been planned to evaluate the pharmacokinetics of this formulation and determine its bioequivalence with the reference product, Galvus Met®, at the same dose.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets	Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets

Timeline

• Start date: 2024-05-23
• Primary completion: 2024-05-25
• Completion: 2024-06-02
• First posted: 2024-02-06
• Last updated: 2024-02-07