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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01755494
First received: December 12, 2012
Last updated: December 12, 2013
Last verified: December 2013

December 12, 2012
December 12, 2013
February 2013
April 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01755494 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability assessment based on medical review of AE reports:physical examination, ECG, heart rate, blood pressure, lab test [ Time Frame: Study duration for individual subject (up to 34 days) when the safety data are collected ] [ Designated as safety issue: Yes ]
    Assessment for 5 mg saxagliptin co-administered with up to 1000 mg metformin XR given either separately, or as a single FDC tablet.
Same as current
Not Provided
Not Provided
 
A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
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

The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus(T2DM)
  • Drug: Saxagliptin 5 mg
    Saxagliptin oral tablet 5mg, single dose
  • Drug: Metformin XR 500 mg
    Metformin XR oral tablet 500 mg, single dose
  • Drug: Mertformin XR 2 x 500 mg
    Metformin XR oral tablet 2 x 500 mg, single dose
  • Drug: Komboglyze XR 5/500 mg
    oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
  • Drug: Komboglyze XR 5/1000 mg
    oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
  • Experimental: Lower dose
    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)
    Interventions:
    • Drug: Saxagliptin 5 mg
    • Drug: Metformin XR 500 mg
    • Drug: Komboglyze XR 5/500 mg
  • Experimental: Higher dose
    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)
    Interventions:
    • Drug: Saxagliptin 5 mg
    • Drug: Mertformin XR 2 x 500 mg
    • Drug: Komboglyze XR 5/1000 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01755494
D1681C00001
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Boaz Hirshberg Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA
Principal Investigator: Haiyan Li Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100191, PR. China
AstraZeneca
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP