| Outcome Measures: |
Primary: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin, Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin, Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin, Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng\*hr/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin, Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Mean Plasma Half-life (T-HALF) of Dapagliflozin, Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin, Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin, Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L), 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose | Secondary: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide, Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide, Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide, Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng\*hr/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide, Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide, Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours., 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting, Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL)., Day 1 (Pre-dose) to Day 2|Mean Change in Fasting Plasma Glucose From Baseline Until Day 2, Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL)., Day 1 (Pre-dose) to Day 2|Mean Total Amount of Glucose Excreted in Urine Over 24 Hours, The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams., Time of dose to 24 hours post-dose, Day 1 to Day 2|Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration., Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported., Day 1 to Day 3|Number of Participants With Marked Hematology Laboratory Abnormalities, LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): \<0.85\*Pre-Rx. Hematocrit (%): \<0.85\*Pre-Rx. Platelet Count (x10\^9 cells per liter:c/L): \<0.85\*LLN or \>1.5\*ULN (if Pre-Rx\<LLN, use \<0.85\*Pre-Rx). Leukocytes (x10\^3 cells per microliter: c/uL): \<0.9\*LLN, \>1.2\*ULN (if Pre-Rx\<LLN, use \<0.85\*Pre-Rx or \>ULN, if Pre- Rx\>ULN, use \>1.15\*Pre-Rx or \<LLN). Neutrophils (Absolute) (x10\^3 c/uL): \<=1.5. Lymphocytes (Absolute) (x10\^3 c/uL): \<0.75 or \>7.5. Monocytes (Absolute) (x10\^3 c/uL): \>2.000. Basophils (x10\^3 c/uL): \>0.4. Eosinophils (Absolute) (x10\^3 c/uL): \>0.75. Blasts (Absolute) (x10\^9 c/L) \> 0., Day 1 (Pre-dose) to Day 3|Number of Participants With Marked Serum Chemistry Abnormalities, LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): \>1.25\*ULN (if Pre-Rx\>ULN, use \>1.25\*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): \>1.1\*ULN (if Pre-Rx\>ULN, use \>1.25\*Pre-Rx). Blood Urea Nitrogen (mg/dL): \>1.1\*ULN (if Pre-Rx\>ULN, use \>1.2\*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): \>1.5\*ULN if Pre-Rx missing or \<= ULN, \>1.33\*Pre-Rx if PreRx \> ULN. Sodium (mmol/L): \>1.05\*ULN, 1.05\*Pre-Rx if Pre-Rx\>ULN: \<0.95\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.05\*Pre-Rx, \<LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): \<0.9\*LLN, \>1.1\*ULN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.1\*Pre-Rx, \<LLN). Phosphorus (mg/dL): \<0.85\*LLN, \>1.25\*ULN (if Pre-Rx\<LLN, \<0.85\*Pre-Rx, \>ULN. if Pre-Rx\>ULN: \>1.25\*Pre-Rx, \<LLN)., Day 1 (Pre-dose) to Day 3|Number of Participants With Marked Abnormalities in Other Chemistry Testing, LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): \<0.8\*LLN, \>1.3\*ULN (if Pre-Rx\<LLN: \<0.8\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>2.0\*Pre-Rx, \<LLN). Protein (grams per deciliter: g/L): \<0.9\*LLN, \>1.1\*ULN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.1\*Pre-Rx, \<LLN). Albumin (g/L): \<0.9\*LLN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx). Uric Acid (mmol/L): \>1.2\*ULN (if Pre-Rx\>ULN: \>1.25\*Pre-Rx). Lactate Dehydrogenase (U/L): \>1.25\*ULN (if Pre-Rx\>ULN: \>1.5\*Pre-Rx), Day 1 (Pre-dose) to Day 3|Number of Participants With Marked Urinalysis Abnormalities, LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): \>=2 (If Pre-Rx \>= 1, \>=2\*Pre-Rx). Glucose, urine (Qualitative): \>=1, (If Pre-Rx \>=1, \>=2\*Pre-Rx). Protein, urine (Qualitative): \>=2 (If Pre-Rx \>=1, \>=2\*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): \>=2 (If Pre-Rx\>=2, \>=4). White Blood Cells (WBC), urine (hpf): \>=2 (If Pre-Rx\>=2, \>=4)., Day 1 (Pre-dose) to Day 3
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| Locations: |
The Children Hospital Of Alabama, Birmingham, Alabama, 35233, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|Nemours Childrens Hospital, Orlando, Florida, 32827, United States|Emory University, Atlanta, Georgia, 30322, United States|Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky, 40202, United States|Lsuhsc-Shreveport, Shreveport, Louisiana, 71103, United States|Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States|Women And Children'S Hopsital Of Buffalo, Buffalo, New York, 14222, United States|Promedica Toledo Children'S Hospital, Toledo, Ohio, 43606, United States|Mercy Children'S Hospital, Toledo, Ohio, 43608, United States|Children'S Hospital Of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Children'S Hospital Of Pittsburgh Of Upmc, Pittsburgh, Pennsylvania, 15224, United States|Methodist Le Bonheur Hlthcare, Memphis, Tennessee, 38103, United States|Christus Santa Rosa Childrens Hospital, San Antonio, Texas, 78207, United States|Local Institution, Guadalajara, Jalisco, 44150, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Veracruz, 91910, Mexico
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