Bioequivalence Study
- Conditions
- Diabetes
- Interventions
- Drug: Saxagliptin/Metformin
- Registration Number
- NCT01874080
- Lead Sponsor
- AstraZeneca
- 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 the body similarly
- 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, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin/Metformin Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2 Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin/Metformin Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2 Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin/Metformin Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2 Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin/Metformin Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2
- Primary Outcome Measures
Name Time Method Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2 Cmax=Maximum observed plasma concentration
CI=Confidence interval
FDC=Fixed dosed combination
XR=Extended releasePoint estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2 AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2 AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity
Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2 Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2 Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) 19 time points up to Day 3 of Periods 1 and 2
- Secondary Outcome Measures
Name Time Method Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D) 19 time points up to Day 3 of Periods 1 and 2 Terminal half life (T-HALF) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D) 19 time points up to Day 3 of Periods 1 and 2 Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D) 19 time points up to Day 3 of Periods 1 and 2 AUC(0-T) for 5-OH Saxagliptin (Treatments A, B, C, and D) 19 time points up to Day 3 of Periods 1 and 2 AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D) 19 time points up to Day 3 of Periods 1 and 2 Safety assessments based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests Up to Day 3 of Periods 1 and 2 and up to 30 days post discontinuation of dosing Parameters will include:
1. Serious adverse events
2. Deaths
3. Adverse events leading to discontinuation
4. Number of subjects with potentially clinically significant changes in vital signs, electrocardiograms (ECGs) or safety laboratory findings defined as meeting marked abnormality criteria
Trial Locations
- Locations (1)
Icon Development Solutions
🇺🇸San Antonio, Texas, United States