Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Completed · Phase 1
Conditions studied: Type 2 Diabetes Mellitus
In brief
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
Key facts
- Study ID
- NCT00899470
- Run by
- AstraZeneca
- People needed
- 24
- Starts
- 2009-06-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2015-06-01
Who can join
Age: 19 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men and women ages 19 to 45 inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2
You may not qualify if…
- Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
- History of allergy or intolerance to metformin or other similar acting agents
- Prior exposure to saxagliptin
- Prior exposure to metformin within 3 months of study drug administration.
- Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
Where it is running
- Mds Pharma Services — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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