A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
NCT ID: NCT01755494
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2013-02-28
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower dose
co-administration of a single oral dose of a 5 mg saxagliptin tablet and a 500 mg metformin XR (Glucophage XR®) tablet vs. single FDC tablet consisting of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR)
Saxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose
Metformin XR 500 mg
Metformin XR oral tablet 500 mg, single dose
Komboglyze XR 5/500 mg
oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
Higher dose
co-administration of a single oral dose of a 5 mg saxagliptin tablet and two (2) 500 mg metformin XR (Glucophage XR®) tablets vs. Single FDC tablet consisting of 5 mg saxagliptin and 1000 mg metformin XR (Kombiglyze XR)
Saxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose
Mertformin XR 2 x 500 mg
Metformin XR oral tablet 2 x 500 mg, single dose
Komboglyze XR 5/1000 mg
oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose
Metformin XR 500 mg
Metformin XR oral tablet 500 mg, single dose
Mertformin XR 2 x 500 mg
Metformin XR oral tablet 2 x 500 mg, single dose
Komboglyze XR 5/500 mg
oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
Komboglyze XR 5/1000 mg
oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Men, ages 18 to 40 years, inclusive. The age difference among the subjects is within 10 years
* Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
* Sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential
Exclusion Criteria
* Current or recent gastrointestinal disease
* Subjects that have lymphocytopenia or thrombocytopenia
* History of autoimmune skin disorder
* Estimatedcreatinine clearance of less than 80 mL/min
18 Years
40 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
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.
Boaz Hirshberg
Role: STUDY_DIRECTOR
Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA
Haiyan Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100191, PR. China
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Beijing, , China
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1681C00001
Identifier Type: -
Identifier Source: org_study_id