NCT01755494

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 2 Diabetes Mellitus(T2DM)

Interventions

Type	Name	Description
DRUG	Saxagliptin 5 mg	Saxagliptin oral tablet 5mg, single dose
DRUG	Metformin XR 500 mg	Metformin XR oral tablet 500 mg, single dose
DRUG	Mertformin XR 2 x 500 mg	Metformin XR oral tablet 2 x 500 mg, single dose
DRUG	Komboglyze XR 5/500 mg	oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
DRUG	Komboglyze XR 5/1000 mg	oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-24
• Last updated: 2013-12-13

Locations

1 site across 1 country: China