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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus(T2DM)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755494

D1681C00001

Details and patient eligibility

About

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

Full 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

Enrollment: 64 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Lower dose

Experimental group

Description:

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)

Treatment:

Drug: Saxagliptin 5 mg

Drug: Metformin XR 500 mg

Drug: Komboglyze XR 5/500 mg

Higher dose

Experimental group

Description:

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)

Treatment:

Drug: Saxagliptin 5 mg

Drug: Mertformin XR 2 x 500 mg

Drug: Komboglyze XR 5/1000 mg