Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components
- Sponsor
- AstraZeneca
- Study ID
- NCT05266404
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Dapagliflozin/sitagliptin FDC — DRUGSubjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.
- Sitagliptin — DRUGSubjects will receive 100 mg single dose of Sitagliptin orally.
- Dapagliflozin — DRUGSubjects will receive 10 mg single dose of Dapagliflozin orally.
Study Details
A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject
Key Dates
- Start date
- Mar 21, 2022
- Status verified
- Jun 2022
- Primary completion
- May 31, 2022
- Completion
- May 31, 2022
Study Design
- Enrollment
- 46 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tabletSubjects will receive single dose of dapagliflozin/sitagliptin fixed dose combination (FDC) (test formulation).
- Active Comparator: Treatment B (Reference Formulation): Dapagliflozin+SitagliptinSubjects will receive single dose of dapagliflozin 10 mg tablet + sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).
Primary Outcome Measure
Area under plasma concentration-time curve from zero to infinity (AUCinf) [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]