A study to assess the bioequivalence of dapagliflozin/metformin XR fixed-dose combination tablets in healthy subjects

Study identifier:D1691C00008

ClinicalTrials.gov identifier:NCT02637037

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

bioequivalence, fixed dose combination tablets, healthy male and female subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon), dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)

Sex

All

Actual Enrollment

80

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 21 Dec 2015
Primary Completion Date: 07 Apr 2016
Study Completion Date: 07 Apr 2016

Study design

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

Verification:

Verified 01 Mar 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria