BIOAVAILABILITY OF GLI/METXR (4/850 mg) (GLMT12-SIL)

Laboratorios Silanes

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01437800

GLMT12-SIL

Details and patient eligibility

About

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).

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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