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Clinical Trial Details

Trial ID: L2379
Source ID: NCT02223065
Associated Drug: Saxagliptin
Title: Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02223065/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin|DRUG: Dapagliflozin
Outcome Measures: Primary: Saxagliptin Maximum Observed Concentrations (Cmax), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1-3 (Period 1) and Day 8-10 (Period 2)|Dapagliflozin Maximum Observed Concentrations (Cmax), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)|Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T]), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1-3 (Period 1) and Day 8-10 (Period 2)|Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T]), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1-3 (Period 1) and Day 8-10 (Period 2)|Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1-3 (Period 1) and Day 8-10 (Period 2)|Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]), 5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state, Day 1-3 (Period 1) and Day 8-10 (Period 2) |
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-09
Completion Date: 2014-12
Results First Posted: 2016-04-27
Last Update Posted: 2016-04-27
Locations:
URL: https://clinicaltrials.gov/show/NCT02223065