Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects. |
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Condition | Diabetes Mellitus |
Intervention | Drug: saxagliptin Drug: metformin XR Drug: saxagliptin + metformin XR (FDC tablet) |
Phase | Phase 1 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT01192139 |
First Received | August 30, 2010 |
Last Updated | April 19, 2011 |
Last verified | April 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | August 30, 2010 |
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Last Updated Date | April 19, 2011 |
Start Date | November 2009 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) |
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Official Title | Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition |
Brief Summary | The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects. |
Detailed Description | This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana) |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Diabetes Mellitus |
Intervention | Drug: saxagliptin Tablets, Oral, 5 mg, once daily, Single dose Other Names: OnglyzaDrug: metformin XR Tablets, Oral, 500 mg. once daily, Single dose Other Names: Glucophage XRDrug: saxagliptin + metformin XR (FDC tablet) Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 30 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
Eligibility Criteria | Inclusion Criteria: - Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations - Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive - Ages 18 to 45, inclusive Exclusion Criteria: - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population - Major surgical procedure within 4 weeks prior to randomization - Positive serology test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) - Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease - History of gastrointestinal disease within the past 3 months - Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator - Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization - Unable to tolerate oral and/or intravenous (IV) medications - Unable to tolerate the puncturing of veins for drawing of blood - Known allergy or hypersensitivity to any component of the study medication - History of any significant drug allergies (such as anaphylaxis or hepatotoxicity) - Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization - Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization - Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01192139 |
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Other Study ID Numbers | CV181-111 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | April 2011 |
Locations[ + expand ][ + ]
Ppd Development, Lp | Austin, Texas, United States, 78744 |
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