Metformin ER 750 mg Tablets, Fed
Condition: Healthy
Intervention: Glucophage® XR 750 mg Tablets; Metformin ER 750 mg Tablets
Intervention description: 1 x 750 mg, single-dose fed; 1 x 750 mg, single-dose fed
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the rate and extent of absorption of metformin from
      a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg
      Tablets under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or
             non-tobacco user for at least 90 days prior to pre-study medical screening).

          -  Body Mass Index (BMI - weight/height²) greater than or equal to 19 kg/m² and less than
             or equal to 30 kg/m².

          -  Availability of subject for the entire study period and willingness to adhere to
             protocol requirements, as evidenced by a signed Informed Consent Form.

          -  Normal findings in the physical examination, 12-lead ECG and vital signs (blood
             pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature
             between 35.8ºC and 37.5ºC).

          -  Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis
             C and HIV, and for female subjects, pregnancy (serum ß-CG).

          -  No clinical laboratory values outside of the acceptable range as defined by BCR,
             unless the Principal Investigator decides they are not clinically significant.

          -  Female subjects who are surgically sterile for at least six months or post-menopausal
             for at least one year, or who will avoid pregnancy prior to the study, during the
             study and up until one month after the end of the study.

        Exclusion Criteria:

          -  Known history of hypersensitivity to metformin (e.g. Glucophage®) and/or related drugs
             such as glyburide (Diaβeta®, Euglucon®), tolbutamide (Orinase®, Apo-chlorpropamide),
             acetohexamide (Dimelor®), chlorpropamide (Diabinese®) and glipizide (Glucotrol®,
             Glibenese®).

          -  Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine,
             musculoskeletal, neurologic, hematological, liver, or kidney disease unless judged no
             clinically significant by the Principal Investigator, or medical designate.

          -  Known history or presence of food allergies, or any condition known to interfere with
             the absorption, distribution, metabolism or excretion of drugs.

          -  Any clinically significant illness during the last four weeks prior to entry into this
             study.

          -  Presence of any significant physical or organ abnormality.

          -  Any subject with a history of drug abuse.

          -  Any psychiatric or psychological disease (including depression) unless deemed not
             clinically significant by the Principal Investigator, or medical designate.

          -  Use of any prescription medication within 14 days preceding entry into this study.

          -  Use of over-the-counter (OTC) medication within seven days preceding entry into this
             study (except for spermicidal/barrier contraceptive products).

          -  Female subjects: use of oral contraceptives or contraceptive implants (Such as
             Norplant®) within 30 days prior to drug administration or a depot injection of
             progestogen drug (e.g. Depro-Provera®) within one year prior to drug administration.

          -  Female subjects: presence of pregnancy or lactation.

          -  Any subject who has had blood withdrawn within 56 days preceding this study, taken
             during the conduct of any clinical study at a facility other than BCR, or within the
             lockout period specified by a previous study conducted at BCR.

          -  Participation in a clinical trial with an investigational drug within 30 days
             preceding this study.

          -  Any subject who has donated blood within 56 days preceding this study.

          -  Any subject who has participated as a plasma donor in a plasmapheresis program within
             seven days preceding this study.

          -  Significant or recent history of asthma (After 12 years of age).

          -  Any subject with a recent (less than one year) history of alcohol abuse.

          -  Intolerance to venipuncture.