Type 2 Diabetes Mellitus(T2DM)
Conditions
Keywords
Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability
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
Interventions
DRUGSaxagliptin 5 mg
Saxagliptin oral tablet 5mg, single dose
Metformin XR oral tablet 500 mg, single dose
DRUGMertformin XR 2 x 500 mg
Metformin XR oral tablet 2 x 500 mg, single dose
DRUGKomboglyze XR 5/500 mg
oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
DRUGKomboglyze XR 5/1000 mg
oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration time curve (AUC) for 5-hydroxy saxagliptin | 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 | — |
| Safety and tolerability assessment based on medical review of AE reports:physical examination, ECG, heart rate, blood pressure, lab test | 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. |
| Maximum plasma concentration (Cmax) for 5-hydroxy saxagliptin | 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 | — |
Countries
China
Outcome results
None listed