Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

Study identifier:CV181-341

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC

Sex

All

Actual Enrollment

72

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Feb 2014
Primary Completion Date: 01 May 2014
Study Completion Date: 01 May 2014

Study design

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

Verification:

Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca

Inclusion and exclusion criteria