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Clinical Trial Details

Trial ID: L5779
Source ID: NCT03138356
Associated Drug: 2.5 Mg Saxagliptin / 5 Mg Dapagliflozin / 850 Mg Metformin Xr Fdc Tablet
Title: Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet|DRUG: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet|DRUG: 5 mg dapagliflozin / 850 mg metformin XR FDC|DRUG: 5 mg dapagliflozin / 1000 mg metformin XR FDC|DRUG: 2.5 mg ONGLYZA® (saxagliptin) tablet|DRUG: 5 mg Forxiga® (dapagliflozin) tablet|DRUG: 500 mg Glucophage XR®
Outcome Measures: Primary: PK assessment: AUC (Area under plasma concentration-time curve from time zero to infinity), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|PK assessment: AUC0-t (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|PK assessment: Cmax (Maximum observed plasma concentration), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4) | Secondary: Secondary PK parameter: tmax (Time to reach maximum observed plasma concentration), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: t½,λz (Terminal elimination half-life), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: tlast (Time of last quantifiable plasma concentration), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: MRT (Mean residence time from zero to infinity (parent drug only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: λz (Terminal elimination rate constant), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: CL/F (Apparent total body clearance of drug from plasma after extravascular administration (parent drug only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: Vz/F (Apparent volume of distribution during terminal phase after extravascular administration (parent drug only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameters: AUC/D (Dose normalized AUC (metformin only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: AUC0-t/D (Dose normalized AUC0-t (metformin only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Secondary PK parameter: Cmax/D (Dose normalized Cmax (metformin only)), To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration., At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)|Number of patients with Adverse Events (AEs), To assess the adverse events as a criteria of safety and tolerability variables., At Day -1, Spontaneous plus Pre-dose, 3, 12, 24, and 48 hours post-dose (Days 1 to 4), 5 to 7 days post-final dose|Vital signs (systolic and diastolic blood pressure [BP]), To assess the vital signs as a criteria of safety and tolerability variables., At Screening, Day -1, Pre-dose and 48 hours (Days 1 to 4), 5 to 7 days post-final dose]|Vital signs (pulse rate), To assess the vital sign as a criteria of safety and tolerability variables., At Screening, Day -1, Pre-dose and 48 hours (Days 1 to 4), 5 to 7 days post-final dose]|Twelve-lead electrocardiograms (ECGs), To assess the cardiovascular system functioning as a criteria of safety and tolerability variables., At Screening, 5 to 7 days post-final dose ]|Physical examination, To assess the physical conditions as a criteria of safety and tolerability variables., At Screening, Day -1 (brief) , Day 4, 72 hours (brief) post-dose (Days 1 to 4), 5 to 7 days post-final dose ]|Body weight, To assess the body weight as a criteria of safety and tolerability variables., At Screening, Day -1, 5 to 7 days post-final dose ]|Laboratory assessments (hematology, clinical chemistry and urinalysis), To assess hematology, clinical chemistry and urinalysis as a criteria of safety and tolerability variables., At Screening, Day -1, Day 4 (72 hours post-dose), Post-study 5 to 7 days post-final dose
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 126
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-05-25
Completion Date: 2017-11-28
Results First Posted:
Last Update Posted: 2017-12-07
Locations: Research Site, Harrow, HA1 3UJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03138356