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

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ClinicalTrials.gov Identifier: NCT01437813
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
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. 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 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



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


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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.