BIOAVAILABILITY OF GLI/METXR (4/850 mg)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Glimepiride / Extended release Metformin (4/850 mg).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Mexican volunteers, considered healthy according to standard screening assessments Aged between 18 and 50 years old Body mass index (BMI) was 18 to 27.5 Exclusion Criteria: Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality Any acute or chronic disease Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glimepiride / Extended release Metformin<br>Pharmaceutical Form: Tablets Dosage: (4/850 mg). Administration way: Oral On fasting conditions | Drug: Glimepiride / Extended release Metformin (4/850 mg).<br>* One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.<br>* Other names: GLIMETXR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile | Cmax, Area Under Curve, Tmax | Predose,0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Any change in health or undesirable experience in volunteers related or unrelated with the experimental drug. Adverse events were determined using clinical and laboratory test results, throughout the study. | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DM2, glimepiride, metformin extended release