Bioequivalence Study
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly |
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Condition | Diabetes |
Intervention | Drug: Saxagliptin/Metformin |
Phase | Phase 1 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT01874080 |
First Received | June 6, 2013 |
Last Updated | November 8, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 6, 2013 |
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Last Updated Date | November 8, 2013 |
Start Date | June 2013 |
Estimated Primary Completion Date | July 2013 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Bioequivalence Study |
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Official Title | Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects Under Fed Conditions |
Brief Summary | The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly |
Detailed Description | Primary Purpose: Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions |
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 |
Intervention | Drug: Saxagliptin/Metformin Other Names: Kombiglyze XR |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 56 |
Estimated Completion Date | July 2013 |
Estimated Primary Completion Date | July 2013 |
Eligibility Criteria | Inclusion Criteria: - Healthy male and female subjects, 18-45 years of age - Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive - Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product Exclusion Criteria: - Any significant acute or chronic medical illness - Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration) - Gastrointestinal (GI) disease that could affect the absorption of study drug - Inability to tolerate oral medication - History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds - Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01874080 |
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Other Study ID Numbers | CV181-208 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | AstraZeneca |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Icon Development Solutions | San Antonio, Texas, United States, 78209 |
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