Bioequivalence Study

Completed · Phase 1

Conditions studied: Diabetes

In brief

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

Key facts

Study ID

NCT01874080

Run by

AstraZeneca

People needed

56

Starts

2013-06-01

Expected to finish

2013-07-01

Last updated by the study team

2015-04-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects, 18-45 years of age
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
• Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

You may not qualify if…

• Any significant acute or chronic medical illness
• Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
• Gastrointestinal (GI) disease that could affect the absorption of study drug
• Inability to tolerate oral medication
• History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
• Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)

Where it is running

• Icon Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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