Status:
COMPLETED
BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Collaborating Sponsors:
Instituto Mexicano del Seguro Social
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01437813
Start Date
January 1 2011
End Date
March 1 2011
Last Update
May 6 2021
Active Locations (1)
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1
Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.
México, Mexico, 14610