An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 30, 2016

Primary Completion Date

May 5, 2016

Study Completion Date

May 5, 2016

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Xigduo XR

a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release

DRUG

Metformin ER (Glucophage® long)

co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).

DRUG

Dapagliflozin (Forxiga)

co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).

Trial Locations (1)

123423

Research Site, Moscow

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Biocard

UNKNOWN

lead

AstraZeneca

INDUSTRY