Bioequivalence Study

April 21, 2015 updated by: AstraZeneca

Bioequivalence Study of the Fixed Dosed 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 Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed 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 Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects Under Fed Conditions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)
Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2
Drug: Saxagliptin/Metformin
Other Names:
  • Kombiglyze XR
Experimental: Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)
Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2
Drug: Saxagliptin/Metformin
Other Names:
  • Kombiglyze XR
Experimental: Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)
Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2
Drug: Saxagliptin/Metformin
Other Names:
  • Kombiglyze XR
Experimental: Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)
Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2
Drug: Saxagliptin/Metformin
Other Names:
  • Kombiglyze XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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 release
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 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
Time Frame: 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
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 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
Time Frame: 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
19 time points up to Day 3 of Periods 1 and 2
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)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
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)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
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)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
19 time points up to Day 3 of Periods 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
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)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
19 time points up to Day 3 of Periods 1 and 2
Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
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)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
19 time points up to Day 3 of Periods 1 and 2
AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D)
Time Frame: 19 time points up to Day 3 of Periods 1 and 2
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
Time Frame: 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
Up to Day 3 of Periods 1 and 2 and up to 30 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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