Status:
COMPLETED
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Healthy
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.
Eligibility Criteria
Inclusion
- Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)
Exclusion
- Familiar or personal history of diabetes
- History of drug or alcohol abuse within the 2 years prior to the study
- A smoking habit greater than 10 cigarettes per day
- History of allergy to the study drugs
- Intercurrent disease
- Intercurrent treatment with any drug
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00941239
Start Date
January 1 2007
End Date
February 1 2007
Last Update
January 30 2018
Active Locations (1)
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1
Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico, 64460