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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Glimepiride/ Extended release Metformin

• Registration Number: NCT01437813
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A: Glimepiride / Extended Release Metformin	Glimepiride/ Extended release Metformin	Pharmaceutical Form: Tablets Dosage: 4 mg / 850 mg Administration way: Oral

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.; 🇲🇽 México, Mexico