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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755494
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : December 13, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus(T2DM) Drug: Saxagliptin 5 mg Drug: Metformin XR 500 mg Drug: Mertformin XR 2 x 500 mg Drug: Komboglyze XR 5/500 mg Drug: Komboglyze XR 5/1000 mg Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : February 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: Saxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose

Drug: Metformin XR 500 mg
Metformin XR oral tablet 500 mg, single dose

Drug: Komboglyze XR 5/500 mg
oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
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)
 Drug: Saxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose

Drug: Mertformin XR 2 x 500 mg
Metformin XR oral tablet 2 x 500 mg, single dose

Drug: Komboglyze XR 5/1000 mg
oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
    Assessment for 5 mg saxagliptin co-administered with up to 1000 mg metformin XR given either separately, or as a single FDC tablet.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755494


Locations
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China
Research Site
Beijing, China
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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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
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01755494    
Other Study ID Numbers: D1681C00001
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013
Keywords provided by AstraZeneca:
Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action