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Completed

NCT Number: NCT01874080

Bioequivalence Study

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Icon Development Solutions

San Antonio, Texas, 78209, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Saxagliptin/Metformin

Drug

Other names: Kombiglyze XR

Primary outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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:

    • Serious adverse events
    • Deaths
    • Adverse events leading to discontinuation
    • Number of subjects with potentially clinically significant changes in vital signs, electrocardiograms (ECGs) or safety laboratory findings defined as meeting marked abnormality criteria

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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