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

NCT01755494 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-12-13

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755494 on ClinicalTrials.gov