Status:
COMPLETED
Bioequivalence Study
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
Primary Purpose: Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01874080
Start Date
June 1 2013
End Date
July 1 2013
Last Update
April 23 2015
Active Locations (1)
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1
Icon Development Solutions
San Antonio, Texas, United States, 78209