A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration (SAXA)
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01755494
First received: December 12, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus(T2DM) |
Drug: Saxagliptin 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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.
| Enrollment: | 64 |
| Study Start Date: | February 2013 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755494
Locations
| China | |
| Bejing, China | |
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
| Study Director: | Boaz Hirshberg | Room No ; C3C7251800 Concord PikePO Box 15437Wilmington, DE19850-5437 |
| Principal Investigator: | Haiyan Li, Professor | Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100083, P.R. China |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01755494 History of Changes |
| Other Study ID Numbers: | D1681C00001 |
| Study First Received: | December 12, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013