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Clinical Trial Details

Trial ID: L4730
Source ID: NCT00897390
Associated Drug: Saxagliptin
Title: Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00897390/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin|DRUG: Metformin IR (glucophage)|DRUG: Saxagliptin + Metformin IR (FDC)
Outcome Measures: Primary: Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]), Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T]), Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax), Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF), Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax), Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Metformin PK Parameter AUC(INF), Single-dose PK parameters of metformin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Metformin PK Parameter AUC(0-T), Single-dose PK parameters of metformin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Metformin PK Parameter Cmax, Single-dose PK parameters of metformin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Metformin PK Parameter T-HALF, Single-dose PK parameters of metformin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Metformin PK Parameter Tmax, Single-dose PK parameters of metformin were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period | Secondary: BMS-510849 PK Parameter AUC(INF), Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|BMS-510849 PK Parameter AUC(0-T), Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|BMS-510849 PK Parameter Cmax, Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|BMS-510849 PK Parameter T-Half, Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|BMS-510849 PK Parameter T-Max, Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data., pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs, An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event., AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.|AEs of Special Interest, See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class \[SOC\]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity., AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).|Number of Participants With Marked Laboratory Abnormalities (MA), Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10\^3 c/uL; absolute neutrophils/bands LN, 1.500x10\^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L., Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Number of Participants With Marked Urinalysis Abnormalities, Protein, Urine Abnormality: if value \>= 2+ (or if pretreatment value \>= 1+, then \>= 2 \* pretreatment). Glucose, Urine Abnormality: if value \>= 2+ (or if pretreatment value \>= 1+, then \>= 2 \* pretreatment). Blood, Urine Abnormality: if value \>= 2+ (or if pretreatment value \>= 1+, then \>= 2 \* pretreatment). White Blood Cell (WBC), Urine Abnormality: if value \>= 2+ (or if pretreatment value \>= 2+, then \>= 4+). Red Blood Cell (RBC), Urine Abnormality: if value \>= 2+ (or if pretreatment value \>= 2+, then \>= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.), Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities, 12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs., At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2009-06
Completion Date: 2009-07
Results First Posted: 2011-01-21
Last Update Posted: 2015-05-21
Locations: Mds Pharma Services, Lincoln, Nebraska, 68502, United States
URL: https://clinicaltrials.gov/show/NCT00897390