The purpose of the study is to compare two fixed dose combination tablets of dapagliflozin/metformin XR in healthy subjects under fasting and fed conditions

Study identifier:D1691C00016

ClinicalTrials.gov identifier:NCT03216278

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A two part bioequivalence study to compare two fixed dose combination (FDC) tablets of dapagliflozin/metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) manufactured at two different plants (Humacao, Puerto Rico and Mount Vernon, US) in healthy subjects under fasting and fed conditions

Medical condition

Healthy subjects in fasted and fed state

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 10/1000mg, Dapagliflozin/metformin XR 10/1000mg, Dapagliflozin/metformin XR 10/1000mg, Dapagliflozin/metformin XR 10/1000mg

Sex

All

Actual enrollment

284

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 26 Sept 2017
Primary Completion Date: 22 May 2018
Study Completion Date: 22 May 2018

Study design

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

Verification:

Verified 01 May 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria