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Clinical Trial Details

Trial ID: L3736
Source ID: NCT02060201
Associated Drug: Saxagliptin
Title: Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin|DRUG: Dapagliflozin|DRUG: Saxagliptin/Dapagliflozin FDC
Outcome Measures: Primary: Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days | Secondary: Cmax for 5-hydroxy (OH) Saxagliptin, 54 time points up to 15 days|AUC(0-T) for 5-hydroxy (OH) Saxagliptin, 54 time points up to 15 days|AUC(INF) for 5-hydroxy (OH) Saxagliptin, 54 time points up to 15 days|Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin, 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days|Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results, Approximately up to 16 days
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2014-02
Completion Date: 2014-05
Results First Posted:
Last Update Posted: 2015-06-10
Locations:
URL: https://clinicaltrials.gov/show/NCT02060201