Overview

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
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 tablet co-administered to healthy subjects in a fasted and in a fed state.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Metformin
Saxagliptin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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