BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study

Laboratorios Silanes S.A. de C.V.24 enrolled

Overview

Objective: The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) 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. A single oral dose of GLI/METXR (4/850 mg) was administered to 24 health Mexican volunteers 30 min after a high fat meal.

Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of both drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, 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. 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. Adverse events were determined using clinical and laboratory test results throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Glimepiride/ Extended release MetforminDRUG

One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.

México, Mexico

Outcomes

Primary Outcomes

Pharmacokinetic Profile

Cmax, Area Under Curve, Tmax

Time frame: 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 Outcomes

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.

Time frame: 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

Data from ClinicalTrials.gov

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