Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 26, 2019

Primary Completion Date

April 2, 2019

Study Completion Date

May 15, 2019

Conditions
Healthy
Interventions
DRUG

Empagliflozin & Metformin (Test)

one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.

DRUG

Empagliflozin & Metformin (Reference)

one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.

Trial Locations (1)

11757

Genuine Research Center GRC, Cairo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hikma Pharma

UNKNOWN

lead

Genuine Research Center, Egypt

INDUSTRY

NCT05132023 - Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany) | Biotech Hunter | Biotech Hunter