MedTrace Logo

BIOAVAILABILITY OF GLI/METXR (4/850 mg)

NCT01437800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-05-06

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Yamanqui Ibañez, M.D · INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437800 on ClinicalTrials.gov