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
NCT03216278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 284
Last updated 2018-05-30
Summary
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
Conditions
- Healthy Subjects in Fasted and Fed State
Interventions
- DRUG
-
Dapagliflozin/metformin XR 5/500mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 5/500 mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 5/500mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 5/500mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 10/1000mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 10/1000mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 10/1000mg
Tablets for oral administration, once daily, once per treatment period
- DRUG
-
Dapagliflozin/metformin XR 10/1000mg
Tablets for oral administration, once daily, once per treatment period
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-26
- Primary Completion
- 2018-05-22
- Completion
- 2018-05-22
- FDA Drug
- Yes
Countries
- Brazil
Study Locations
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