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Clinical Trial Details

Trial ID: L5365
Source ID: NCT03169959
Associated Drug: 2.5 Mg Saxagliptin Tablet
Title: A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 2.5 mg Saxagliptin tablet|DRUG: 5 mg dapagliflozin / 1000 mg metformin XR tablet|DRUG: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR|DRUG: 5 mg saxagliptin|DRUG: 10 mg dapagliflozin / 1000 mg metformin XR tablet|DRUG: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR
Outcome Measures: Primary: Area under plasma concentration-time curve from time zero to infinity (AUC), To assess pharmacokinetics (PK) in terms of AUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t), To assess PK in terms of AUC0-t in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)|Maximum observed plasma concentration (Cmax), To assess PK in terms of Cmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) | Secondary: Time to reach maximum observed plasma concentration (tmax), To assess PK in terms of tmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2), To assess PK in terms of t1/2 in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (parent drug only) (MRT), To assess PK in terms of MRT in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Terminal elimination rate constant (λz), To assess PK in terms of λz in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Apparent total body clearance of drug from plasma after extravascular administration (CL/F), To assess PK in terms of CL/F in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Apparent volume of distribution (V/F), To assess PK in terms of V/F in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Ratio of metabolite AUC to parent AUC (MRAUC), To assess PK in terms of MRAUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers., At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours|Number of subjects with Adverse Events (AEs), To assess AEs as a criteria of safety and tolerability variables., A Day -1, spontaneous plus pre-dose, 1, 2, 3, 24, and 48 hours post-dose|Systolic and diastolic blood pressure [BP], To assess the systolic and diastolic blood pressure as a criteria of safety and tolerability variables, At screening (Day -28), Day -1, pre-dose, 71 hours post-dose and 5 to 7 days post-final dose follow-up|Pulse rate, To assess the pulse rate as a criteria of safety and tolerability variables, From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)|Twelve-lead electrocardiograms (ECGs), To assess the cardiovascular system functioning as a criteria of safety and tolerability variables., From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)|Physical examination, To assess a complete physical examinations (general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal and neurological systems) and a brief physical examinations (general appearance, skin, abdomen, cardiovascular system and respiratory) as a criteria of safety and tolerability variables. A complete physical examination will be performed at the screening visit., From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)|Laboratory assessments of Hematology, To assess the count of white blood cell (WBC), red blood cell (RBC) and platelets; absolute count of neutrophils, lymphocytes, monocytes, eosinophils, basophils and reticulocytes; levels of Hemoglobin (Hb), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) in blood as a criteria of safety and tolerability variables., From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)|Laboratory assessments of Clinical chemistry, To assess the levels of electrolytes (sodium, potassium, magnesium, chloride, calcium, phosphate), urea, creatinine, albumin, glucose (fasting), C-reactive protein (CRP), thyroxine (T4), thyroid-stimulating hormone (TSH), liver enzymes (alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Gamma glutamyl transpeptidase (GGT)), bilirubin (total and unconjugated) and follicle-stimualting hormone (FSH) in serum as a criteria of safety and tolerability variables., From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)|Laboratory assessments of urinalysis, To assess the presence of glucose, protein, blood and microscopy (RBC, WBC, casts (cellualr, granular, hyaline) in urine as a criteria of safety and tolerability variables., From Screening (Day -28 to Day -1) to Follow-up (5-7days post final dose)
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 85
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-05-29
Completion Date: 2017-08-03
Results First Posted:
Last Update Posted: 2017-08-14
Locations: Research Site, Baltimore, Maryland, 21225, United States
URL: https://clinicaltrials.gov/show/NCT03169959