Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Key facts

Study ID

NCT01068717

Run by

AstraZeneca

People needed

27

Starts

2010-03-01

Expected to finish

2010-03-01

Last updated by the study team

2015-05-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women, aged 18 to 55 years, inclusive
• Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
• Body Mass Index of 18 to 32 kg/m\^2, inclusive

You may not qualify if…

• 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 DPP-4 inhibitors or related compounds
• History of allergy or intolerance to metformin or other similar acting agents
• Previous exposure to saxagliptin
• Exposure to metformin within 3 months pervious to study drug administration
• Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

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