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NCT Number: NCT01755494

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus(T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Beijing, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Saxagliptin 5 mg

Drug

Saxagliptin oral tablet 5mg, single dose

Metformin XR 500 mg

Drug

Metformin XR oral tablet 500 mg, single dose

Mertformin XR 2 x 500 mg

Drug

Metformin XR oral tablet 2 x 500 mg, single dose

Komboglyze XR 5/500 mg

Drug

oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose

Komboglyze XR 5/1000 mg

Drug

oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Acronym: SAXA

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2012
Registry last updated
Dec 13, 2013

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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