NCT05266404View on ClinicalTrials.gov

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 21, 2022

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Interventions
DRUG

Dapagliflozin/sitagliptin FDC

Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.

DRUG

Sitagliptin

Subjects will receive 100 mg single dose of Sitagliptin orally.

DRUG

Dapagliflozin

Subjects will receive 10 mg single dose of Dapagliflozin orally.

Trial Locations (1)

14050

Research Site, Berlin

Sponsors

Lead Sponsor

AstraZeneca

Collaborators (1)

Parexel
All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY