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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01755494
• Date of registration: 12/12/2012
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration SAXA
• Scientific 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
• Date of first enrolment: February 2013
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01755494
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Haiyan Li
• Affiliation: Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100191, PR. China

• Name: Boaz Hirshberg
• Affiliation: Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus(T2DM)

Intervention(s)

Drug: Metformin XR 500 mg

Drug: Komboglyze XR 5/1000 mg

Drug: Mertformin XR 2 x 500 mg

Drug: Komboglyze XR 5/500 mg

Drug: Saxagliptin 5 mg

Primary Outcome(s)

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]

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]

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]

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]

Secondary Outcome(s)

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]

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]

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]

Secondary ID(s)

D1681C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb