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More info
You can access this
clinical trial
if you have
Healthy
and you are
between 18 and 50
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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. 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). 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. Adverse events were determined using clinical and laboratory test results, throughout the study.

Provided treatments

  • Drug: Glimepiride/extended release Metformin (4/850 mg).

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01437800. The sponsor of the trial is Laboratorios Silanes S.A. de C.V. and it is looking for 24 volunteers for the current phase.
Official trial title:
Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) in Healthy Mexican Volunteers