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

• ClinicalTrials.gov Identifier: NCT01437813
• Recruitment Status: Completed
• First Posted: September 21, 2011
• Last Update Posted: September 21, 2011
• Sponsor: Laboratorios Silanes S.A. de C.V.
• Collaborator: Instituto Mexicano del Seguro Social
• Information provided by (Responsible Party): Laboratorios Silanes S.A. de C.V.

Study Description

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. 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 botk drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. Adverse events were determined using clinical and laboratory test results throughout the study.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Glimepiride/extended release Metformin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers
• Study Start Date: January 2011
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Intervention Details:

• 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 Name: GLIMETXR

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic Profile [ Time Frame: 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 :

1. Adverse Events [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Mexico

Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.

México, Mexico, 14610

Sponsors and Collaborators

Laboratorios Silanes S.A. de C.V.

Instituto Mexicano del Seguro Social

Investigators

• Principal Investigator: Yamanqui Ibañez, Dr.; INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.

More Information

Publications of Results:

Badian M, Korn A, Lehr KH, Malerczyk V, Waldhäusl 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.

Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. Review.

Campbell RK. Glimepiride: role of a new sulfonylurea in the treatment of type 2 diabetes mellitus. Ann Pharmacother. 1998 Oct;32(10):1044-52. Review.

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. Review.

DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999 Aug 17;131(4):281-303. Review.

• Responsible Party: Laboratorios Silanes S.A. de C.V.
• ClinicalTrials.gov Identifier: NCT01437813 History of Changes
• Other Study ID Numbers: GLMT13-SIL
• First Posted: September 21, 2011
• Last Update Posted: September 21, 2011
• Last Verified: January 2011

Keywords provided by Laboratorios Silanes S.A. de C.V.:

DM2; glimepiride; metformin extended release

Additional relevant MeSH terms:

Metformin; Glimepiride; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors