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

PHASE1CompletedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

May 25, 2017

Primary Completion Date

November 28, 2017

Study Completion Date

November 28, 2017

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet

Used in Treatment B and Treatment E.

DRUG

2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet

Used in Treatment A and Treatment D.

DRUG

5 mg dapagliflozin / 850 mg metformin XR FDC

Used in Treatment H.

DRUG

5 mg dapagliflozin / 1000 mg metformin XR FDC

Used in Treatment G.

DRUG

2.5 mg ONGLYZA® (saxagliptin) tablet

Used in treatments C and F.

DRUG

5 mg Forxiga® (dapagliflozin) tablet

Used in treatments C, F and I.

DRUG

500 mg Glucophage XR®

Used in treatments C, F and I.

Trial Locations (1)

HA1 3UJ

Research Site, Harrow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY