BIOAVAILABILITY OF GLI/METXR (4/850 mg)

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

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Glimepiride / Extended release Metformin (4/850 mg).DRUG

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

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)

Investigacion Farmacologica 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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