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Clinical Trial Details

Trial ID: L3350
Source ID: NCT01068717
Associated Drug: Saxagliptin, 2.5 Mg + Metformin, 500 Mg (Fasted State)
Title: Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01068717/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)|DRUG: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)|DRUG: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)|DRUG: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Outcome Measures: Primary: Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4|Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States, Days 1, 2, and 3 of Periods 1, 2, 3, and 4 | Secondary: Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation, An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization., Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4|Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results, Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH., At screening visit, at Day -1 of Periods 1 through 4, and at discharge|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results, Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes., At screening visit, Day -1 of Period 1, and at study discharge|Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate, Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes., At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2010-03
Completion Date: 2010-03
Results First Posted: 2011-10-21
Last Update Posted: 2015-05-12
Locations: Ppd Development, Lp, Austin, Texas, 78744, United States
URL: https://clinicaltrials.gov/show/NCT01068717