Bioequivalence Study

Study identifier:CV181-208

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects under Fed Conditions

Medical condition

diabetes

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Saxagliptin/Metformin

Sex

All

Actual Enrollment

56

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Jun 2013
Primary Completion Date: 01 Jul 2013
Study Completion Date: 01 Jul 2013

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

AstraZeneca

Inclusion and exclusion criteria