Status:
COMPLETED
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00899470
Start Date
June 1 2009
End Date
August 1 2009
Last Update
June 1 2015
Active Locations (1)
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1
Mds Pharma Services
Lincoln, Nebraska, United States, 68502