BIOAVAILABILITY OF GLI/METXR (4/850 mg)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01437800

Acronym

GLMT12-SIL

Enrollment

Registered

2011-09-21

Start date

2011-01-31

Completion date

2011-03-31

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

DM2, glimepiride, metformin extended release

Brief summary

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

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.

Interventions

DRUGGlimepiride / Extended release Metformin (4/850 mg).

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic Profile	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	Cmax, Area Under Curve, Tmax

Secondary

Measure	Time frame	Description
Adverse events	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	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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026