NCT01437800

BIOAVAILABILITY OF GLI/METXR (4/850 mg)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glimepiride / Extended release Metformin (4/850 mg).	One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2011-09-21
• Last updated: 2021-05-06

Locations

1 site across 1 country: Mexico