1. Institutionalized subjects will not be used. 2 Social Habits: 
1. Use of any tobacco products. 
2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. 
3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication. 
4. Any recent, significant change in dietary or exercise habits. 
5. Positive test for any drug included in the urine drug screen. 
3. Medications: 
1. Use of any medication within the 14 days prior to the initial dose of study medication. 
2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. 
3. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication. 
4. Diseases: 
a. History of any significant chronic disease and/or hepatitis. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing. 
d. Positive HIV, Hepatitis B, or Hepatitis C test. e. Renal disease or renal dysfunction (as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance). 
5. Abnormal and clinically significant laboratory test results: 
1. Clinically significant deviation from the Guide for Clinically Relevant Abnormalities (see Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 
2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 
8. Allergy or hypersensitivity to metformin hydrochloride. 9. History of difficulty in swallowing medication, or any gastrointestinal disorder which could affect the drug absorption.       
    

NCT00650312_exc_T5
Drug
tobacco products
NCT00650312_exc_T17
Drug
medication
NCT00650312_exc_T18
Temporal
within the 14 days prior
NCT00650312_exc_T19
Reference_point
the initial dose of study medication
NCT00650312_exc_T20
Drug
medication known to alter hepatic enzyme activity
NCT00650312_exc_T21
Temporal
within 28 days prior
NCT00650312_exc_T22
Reference_point
the initial dose of study medication
NCT00650312_exc_T24
Drug
hormonal contraceptives
NCT00650312_exc_T25
Drug
hormonal replacement therapy
NCT00650312_exc_T26
Temporal
within three months prior
NCT00650312_exc_T27
Reference_point
the initial dose of study medication
NCT00650312_exc_T31
Observation
History
NCT00650312_exc_T32
Condition
chronic disease
NCT00650312_exc_T33
Condition
hepatitis
NCT00650312_exc_T34
Qualifier
significant
NCT00650312_exc_T36
Scope
significant chronic disease and/or hepatitis
NCT00650312_exc_T37
Condition
drug abuse
NCT00650312_exc_T38
Condition
alcohol abuse
NCT00650312_exc_T39
Observation
History
NCT00650312_exc_T41
Measurement
HIV test
NCT00650312_exc_T42
Measurement
Hepatitis B test
NCT00650312_exc_T43
Measurement
Hepatitis C test
NCT00650312_exc_T44
Scope
HIV, Hepatitis B, or Hepatitis C test
NCT00650312_exc_T45
Value
Positive
NCT00650312_exc_T50
Condition
Renal disease
NCT00650312_exc_T51
Condition
renal dysfunction
NCT00650312_exc_T52
Measurement
serum creatinine levels
NCT00650312_exc_T53
Value
greater than or equal to 1.5 mg/dL
NCT00650312_exc_T54
Person
males
NCT00650312_exc_T55
Person
females
NCT00650312_exc_T56
Value
greater than or equal to 1.4 mg/dL
NCT00650312_exc_T57
Condition
abnormal creatinine clearance
NCT00650312_exc_T58
Scope
greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females)
NCT00650312_exc_T59
Scope
serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance
NCT00650312_exc_T60
Scope
Renal disease or renal dysfunction
NCT00650312_exc_T69
Condition
Abnormal ECG tracing
NCT00650312_exc_T76
Drug
metformin hydrochloride
NCT00650312_exc_T77
Condition
hypersensitivity
NCT00650312_exc_T78
Condition
Allergy
NCT00650312_exc_T79
Condition
difficulty in swallowing medication
NCT00650312_exc_T81
Observation
History
NCT00650312_exc_T82
Condition
gastrointestinal disorder
NCT00650312_exc_T83
Qualifier
affect the drug absorption