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

NCT01755494 | Completed Phase 1

• 1 other identifier: D1681C00001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus(T2DM)

Keywords

Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

• 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

Study Arms (2)

Lower dose

EXPERIMENTAL

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; Drug: Metformin XR 500 mg; Drug: Komboglyze XR 5/500 mg

Higher dose

EXPERIMENTAL

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; Drug: Mertformin XR 2 x 500 mg; Drug: Komboglyze XR 5/1000 mg

Interventions

Saxagliptin 5 mg DRUG

Saxagliptin oral tablet 5mg, single dose

Higher dose; Lower dose

Metformin XR 500 mg DRUG

Metformin XR oral tablet 500 mg, single dose

Lower dose

Mertformin XR 2 x 500 mg DRUG

Metformin XR oral tablet 2 x 500 mg, single dose

Higher dose

Komboglyze XR 5/500 mg DRUG

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

Lower dose

Komboglyze XR 5/1000 mg DRUG

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

Higher dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Research Site

Beijing, China

Location

Related Links

• D1681C00001.pdf

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Boaz Hirshberg

  Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA

  STUDY DIRECTOR

• Haiyan Li

  Peking University Third Hospital (PU3), 49 North Garden Road, Haidian District, Beijing 100191, PR. China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 24, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

CN (1)