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

This study has been completed.
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01437813
First received: September 19, 2011
Last updated: September 20, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Glimepiride/extended release Metformin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Cmax, Area Under Curve, Tmax


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 24
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437813

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:

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01437813     History of Changes
Other Study ID Numbers: GLMT13-SIL
Study First Received: September 19, 2011
Last Updated: September 20, 2011
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Laboratorios Silanes S.A. de C.V.:
DM2
glimepiride
metformin extended release

Additional relevant MeSH terms:
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013