Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Healthy
Interventions
DRUG

Empagliflozin

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

DRUG

Metformin

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

DRUG

Empagliflozin

Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

DRUG

Metformin

Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Trial Locations (1)

Unknown

1276.27.001 Boehringer Ingelheim Investigational Site, Saint Petersburg

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY