Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
NCT ID: NCT01068717
Last Updated: 2015-05-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2010-03-31
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
NCT01068743
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
NCT00899470
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
NCT00897390
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
NCT01192152
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
NCT01441869
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)
Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)
Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)
Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
* Body Mass Index of 18 to 32 kg/m\^2, inclusive
Exclusion Criteria
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to DPP-4 inhibitors or related compounds
* History of allergy or intolerance to metformin or other similar acting agents
* Previous exposure to saxagliptin
* Exposure to metformin within 3 months pervious to study drug administration
* Estimated creatinine clearance of \<80 mL/min using the Cockcroft Gault formula
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ppd Development, Lp
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CV181-118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.