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A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration (SAXA)

Primary Purpose

Type 2 Diabetes Mellitus(T2DM)

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Saxagliptin 5 mg
Metformin XR 500 mg
Mertformin XR 2 x 500 mg
Komboglyze XR 5/500 mg
Komboglyze XR 5/1000 mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus(T2DM) focused on measuring Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Chinese ethnicity which is defined as having both parents and 4 grandparents who are Chinese
  • Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Men, ages 18 to 40 years, inclusive. The age difference among the subjects is within 10 years
  • Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
  • Sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Current or recent gastrointestinal disease
  • Subjects that have lymphocytopenia or thrombocytopenia
  • History of autoimmune skin disorder
  • Estimatedcreatinine clearance of less than 80 mL/min

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lower dose

Higher dose

Arm Description

co-administration of a single oral dose of a 5 mg saxagliptin tablet and a 500 mg metformin XR (Glucophage XR®) tablet vs. single FDC tablet consisting of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR)

co-administration of a single oral dose of a 5 mg saxagliptin tablet and two (2) 500 mg metformin XR (Glucophage XR®) tablets vs. Single FDC tablet consisting of 5 mg saxagliptin and 1000 mg metformin XR (Kombiglyze XR)

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Maximum plasma concentration (Cmax) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Area under plasma concentration time curve (AUC) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Area under plasma concentration time curve (AUC) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets

Secondary Outcome Measures

Maximum plasma concentration (Cmax) for 5-hydroxy saxagliptin
Area under plasma concentration time curve (AUC) for 5-hydroxy saxagliptin
Safety and tolerability assessment based on medical review of AE reports:physical examination, ECG, heart rate, blood pressure, lab test
Assessment for 5 mg saxagliptin co-administered with up to 1000 mg metformin XR given either separately, or as a single FDC tablet.

Full Information

First Posted
December 12, 2012
Last Updated
December 12, 2013
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01755494
Brief Title
A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
Acronym
SAXA
Official Title
A Single-centre, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.
Detailed Description
A Single-centre, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration of the Individual Components in two cohorts of Healthy Chinese Subjects under Fed Conditions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus(T2DM)
Keywords
Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower dose
Arm Type
Experimental
Arm Description
co-administration of a single oral dose of a 5 mg saxagliptin tablet and a 500 mg metformin XR (Glucophage XR®) tablet vs. single FDC tablet consisting of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR)
Arm Title
Higher dose
Arm Type
Experimental
Arm Description
co-administration of a single oral dose of a 5 mg saxagliptin tablet and two (2) 500 mg metformin XR (Glucophage XR®) tablets vs. Single FDC tablet consisting of 5 mg saxagliptin and 1000 mg metformin XR (Kombiglyze XR)
Intervention Type
Drug
Intervention Name(s)
Saxagliptin 5 mg
Intervention Description
Saxagliptin oral tablet 5mg, single dose
Intervention Type
Drug
Intervention Name(s)
Metformin XR 500 mg
Intervention Description
Metformin XR oral tablet 500 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Mertformin XR 2 x 500 mg
Intervention Description
Metformin XR oral tablet 2 x 500 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Komboglyze XR 5/500 mg
Intervention Description
oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
Intervention Type
Drug
Intervention Name(s)
Komboglyze XR 5/1000 mg
Intervention Description
oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Title
Maximum plasma concentration (Cmax) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Title
Area under plasma concentration time curve (AUC) for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Title
Area under plasma concentration time curve (AUC) for metformin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin XR and saxaglitpin tablets
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) for 5-hydroxy saxagliptin
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Title
Area under plasma concentration time curve (AUC) for 5-hydroxy saxagliptin
Time Frame
Plasma samples at 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours post-dose
Title
Safety and tolerability assessment based on medical review of AE reports:physical examination, ECG, heart rate, blood pressure, lab test
Description
Assessment for 5 mg saxagliptin co-administered with up to 1000 mg metformin XR given either separately, or as a single FDC tablet.
Time Frame
Study duration for individual subject (up to 34 days) when the safety data are collected

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chinese ethnicity which is defined as having both parents and 4 grandparents who are Chinese Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Men, ages 18 to 40 years, inclusive. The age difference among the subjects is within 10 years Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2 Sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential Exclusion Criteria: Any significant acute or chronic medical illness Current or recent gastrointestinal disease Subjects that have lymphocytopenia or thrombocytopenia History of autoimmune skin disorder Estimatedcreatinine clearance of less than 80 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boaz Hirshberg
Organizational Affiliation
Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haiyan Li
Organizational Affiliation
Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100191, PR. China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
Country
China

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1189&filename=D1681C00001.pdf
Description
D1681C00001.pdf

Learn more about this trial

A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration

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