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Clinical Trial Details

Trial ID: L2151
Source ID: NCT01365091
Associated Drug: Saxagliptin/Metformin Fixed-Dose Combination (Fdc)
Title: Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01365091/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin/metformin fixed-dose combination (FDC)|DRUG: Saxagliptin|DRUG: Metformin extended-release (XR)|DRUG: Saxagliptin/Metformin FDC|DRUG: Metformin
Outcome Measures: Primary: Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets, Days 1, 2, and 3 of Periods 1 and 2|AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets, AUC=Area under the concentration-time curve, Days 1, 2, and 3 of Periods 1 and 2|AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets, AUC=Area Under the Concentration-time Curve, Days 1, 2, and 3 of Periods 1 and 2 | Secondary: Number of Participants With Death as Outcome and Serious Adverse Events (SAEs), SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization., Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 112
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2011-06
Completion Date: 2011-11
Results First Posted: 2013-08-19
Last Update Posted: 2015-05-08
Locations: Local Institution, Campinas, Sao Paulo, 13073, Brazil
URL: https://clinicaltrials.gov/show/NCT01365091