BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study (GLMT13)

Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Glimepiride/ Extended release Metformin

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • México, Mexico, 14610
    • Investigacion Farmacologica Y Biofarmaceutica, S.A. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Glimepiride / Extended Release Metformin; Pharmaceutical Form: Tablets Dosage: 4 mg / 850 mg Administration way: Oral	Drug: Glimepiride/ Extended release Metformin; One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration.; Other Names: GLIMETXR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Profile	Cmax, Area Under Curve, Tmax	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Laboratorios Silanes S.A. de C.V.
• Collaborators: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Yamanqui Ibañez, Dr., INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.

Publications and helpful links

General Publications

• Badian M, Korn A, Lehr KH, Malerczyk V, Waldhausl W. Determination of the absolute bioavailability of glimepiride (HOE 490), a new sulphonylurea. Int J Clin Pharmacol Ther Toxicol. 1992 Nov;30(11):481-2. No abstract available.
• Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.
• Campbell RK. Glimepiride: role of a new sulfonylurea in the treatment of type 2 diabetes mellitus. Ann Pharmacother. 1998 Oct;32(10):1044-52. doi: 10.1345/aph.17360.
• Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med. 1997 Jan;102(1):99-110. doi: 10.1016/s0002-9343(96)00353-1.
• DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999 Aug 17;131(4):281-303. doi: 10.7326/0003-4819-131-4-199908170-00008.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: glimepiride; DM2; metformin extended release
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Metformin; Glimepiride
• Other Study ID Numbers: GLMT13-SIL