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Clinical Trial Details

Trial ID: L1893
Source ID: NCT01755494
Associated Drug: Saxagliptin 5 Mg
Title: A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
Acronym: SAXA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus(T2DM)
Interventions: DRUG: Saxagliptin 5 mg|DRUG: Metformin XR 500 mg|DRUG: Mertformin XR 2 x 500 mg|DRUG: Komboglyze XR 5/500 mg|DRUG: Komboglyze XR 5/1000 mg
Outcome Measures: Primary: Maximum plasma concentration (Cmax) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose|Maximum plasma concentration (Cmax) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose|Area under plasma concentration time curve (AUC) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose|Area under plasma concentration time curve (AUC) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose | Secondary: Maximum plasma concentration (Cmax) for 5-hydroxy saxagliptin, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose|Area under plasma concentration time curve (AUC) for 5-hydroxy saxagliptin, Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose|Safety and tolerability assessment based on medical review of AE reports:physical examination, ECG, heart rate, blood pressure, lab test, Assessment for 5 mg saxagliptin co-administered with up to 1000 mg metformin XR given either separately, or as a single FDC tablet., Study duration for individual subject (up to 34 days) when the safety data are collected
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-02
Completion Date: 2013-04
Results First Posted:
Last Update Posted: 2013-12-13
Locations: Research Site, Beijing, China
URL: https://clinicaltrials.gov/show/NCT01755494