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About
The purpose of this study is compare the relative bioavailability of 500 mg Metformin Hydrochloride Extended Release Tablets by Alpharma with that of 500 mg CLUCOPHAGE® XR Tablets distributed by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg extended-release tablet) in healthy adult volunteers under fasting conditions.
Full description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: A Relative Bioavailability Study of 500 mg Metformin Hydrochloride Extended Release Tablets Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Enrollment
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Volunteers
Inclusion criteria
Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults -1983 Metropolitan Height and Weight Table.
Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. -The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
The screening clinical laboratory procedures will include:
If female and:
Exclusion criteria
40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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