Bioequivalence study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects

Study identifier:D168AC00002

ClinicalTrials.gov identifier:NCT03138356

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed- and Fasted State Bioequivalence of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet, 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet, 5 mg dapagliflozin / 850 mg metformin XR FDC, 5 mg dapagliflozin / 1000 mg metformin XR FDC, 2.5 mg ONGLYZA® (saxagliptin) tablet, 5 mg Forxiga® (dapagliflozin) tablet, 500 mg Glucophage XR®

Sex

All

Actual Enrollment

126

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 25 May 2017
Primary Completion Date: 28 Nov 2017
Study Completion Date: 28 Nov 2017

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria