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

AstraZeneca64 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus(T2DM)

Interventions

Saxagliptin 5 mgDRUG

Saxagliptin oral tablet 5mg, single dose

Metformin XR 500 mgDRUG

Metformin XR oral tablet 500 mg, single dose

Mertformin XR 2 x 500 mgDRUG

Metformin XR oral tablet 2 x 500 mg, single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Beijing, China

Outcomes

Primary Outcomes

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