BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study — GLMT13  

Healthy Clinical Trial

Official title: Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers

Status Completed

Clinical Trial Summary

Objective:

The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy Mexican volunteers.

Methods: A prospective, longitudinal, open label, non randomized study, was performed. A single oral dose of GLI/METXR (4/850 mg) was administered to 24 health Mexican volunteers 30 min after a high fat meal.

Clinical Trial Description

Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of both drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. The pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 / 2 of glimepiride and metformin. The statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin. Adverse events were determined using clinical and laboratory test results throughout the study. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT01437813
• Study type: Interventional
• Source: Laboratorios Silanes S.A. de C.V.
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Completion date: March 2011