The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
- Sponsor
- AstraZeneca
- Study ID
- NCT03216278
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Subjects in Fasted and Fed State
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Dapagliflozin/metformin XR 5/500mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 5/500 mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 5/500mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 5/500mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 10/1000mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 10/1000mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 10/1000mg — DRUGTablets for oral administration, once daily, once per treatment period
- Dapagliflozin/metformin XR 10/1000mg — DRUGTablets for oral administration, once daily, once per treatment period
Study Details
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
Key Dates
- Start date
- Sep 26, 2017
- Status verified
- May 2018
- Primary completion
- May 22, 2018
- Completion
- May 22, 2018
Study Design
- Enrollment
- 284 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment ADapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fed
- Active Comparator: Treatment BDapagliflozin/metformin XR 5/500 Humacao Reference Product Fed
- Experimental: Treatment CDapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fasted
- Active Comparator: Treatment DDapagliflozin/metformin XR 5/500 Humacao Reference Product Fasted
- Experimental: Treatment EDapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fed
- Active Comparator: Treatment FDapagliflozin/metformin XR 10/1000 Humacao Reference Product Fed
- Experimental: Treatment GDapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fasted
- Active Comparator: Treatment HDapagliflozin/metformin XR 10/1000 Humacao Reference Product Fasted
Primary Outcome Measure
Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state [ Time Frame: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times ]