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Clinical Trial Details

Trial ID: L7345
Source ID: NCT01305551
Associated Drug: Saxagliptin
Title: BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Metformin XR|DRUG: Saxagliptin/Metformin XR FDC
Outcome Measures: Primary: Evidence of BE on single-dose pharmacokinetic parameters maximum observed concentration (Cmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data., 48 hours after dosing|Evidence of BE on single-dose pharmacokinetic parameters time of maximum observed concentration (Tmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data., 48 hours after dosing|Evidence of BE on single-dose pharmacokinetic parameters (AUC(0-T) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data., Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)), 48 hours after dosing|Evidence of BE on single-dose pharmacokinetic parameters area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data., 48 hours after dosing|Evidence of BE on single-dose pharmacokinetic parameters half-life (T-HALF) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data., 48 hours after dosing | Secondary: Number of Participants with Adverse Events as a Measure of Safety and Tolerability, 3 days after dosing|Active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin, from 5 mg Saxagliptin/500 mg Metformin XR FDC tablet & from 5 mg Onglyza administered together with 500 mg Glifage® XR in single-dose fed & fasted state pharmacokinetics in healthy subjects, Amount of the active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin (BMS-510849), from the 5 mg Saxagliptin/500 mg Metformin XR FDC tablet and from 5 mg Onglyza™ administered together with 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) in single-dose fed and fasted state pharmacokinetics in healthy subjects, 3 days after dosing
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2011-03
Completion Date: 2011-03
Results First Posted:
Last Update Posted: 2014-06-05
Locations: Local Institution, Campinas, Sao Paulo, 13073, Brazil
URL: https://clinicaltrials.gov/show/NCT01305551