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BIOAVAILABILITY OF GLI/METXR (4/850 mg) — GLMT12-SIL  

Healthy Clinical Trial

Official title:
Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) in Healthy Mexican Volunteers

Clinical Trial Summary

Objective: The purpose of this study is to evaluate the oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting conditions. Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24 volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg).

Clinical Trial Description

Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted for each volunteer, 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 Adverse events were determined using clinical and laboratory test results, throughout the study. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01437800
Study type Interventional
Source Laboratorios Silanes S.A. de C.V.
Contact
Status Completed
Phase Phase 1
Start date January 2011
Completion date March 2011
View Details
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