Status:
COMPLETED
BIOAVAILABILITY OF GLI/METXR (4/850 mg)
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 oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting ...
Detailed Description
Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted for e...
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
NCT01437800
Start Date
January 1 2011
End Date
March 1 2011
Last Update
May 6 2021
Active Locations (1)
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1
Investigacion Farmacologica Y Biofarmaceutica, S.A. de C.V.
México, Mexico