BIOAVAILABILITY OF GLI/METXR (4/850 mg)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-03-31

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).

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glimepiride / Extended release Metformin

Pharmaceutical Form: Tablets Dosage: (4/850 mg). Administration way: Oral On fasting conditions

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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Glimepiride / 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.

Intervention Type DRUG

Other Intervention Names

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GLIMETXR

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes