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Clinical Trial Details

Trial ID: L1966
Source ID: NCT03776227
Associated Drug: Sotagliflozin (Sar439954)
Title: A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Healthy Subjects
Interventions: DRUG: sotagliflozin (SAR439954)
Outcome Measures: Primary: Cmax, Maximum plasma concentration observed, Day 1 of each period|AUC 0-72h (area under the curve), Truncated AUC 0-72h, Day 1 to Day 3 of each period | Secondary: Time to reach Cmax (tmax), Time to reach Cmax, Day 1 of each period|Terminal half-life (t1/2z), Terminal half-life associated with the terminal slope (λz), Day 1 to Day 7 of each period|Area under the plasma concentration versus time curve (AUClast), Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast, Day 1 to Day 7 of each period|Adverse events, Number of participants with adverse events, Day 1 to Day 7 of each period|Electrocardiograms (ECGs), Number of patients with clinically significant changes in electrocardiograms (ECGs), Day 1 to Day 7 of each period|Vital signs, Number of patients with clinically significant changes in vital signs, Day 1 to Day 7 of each period|Clinical laboratory tests, Number of patients with clinically significant changes in clinical laboratory tests, Day 1 to Day 7 of each period|Area under the curve (AUC), Area under the plasma concentration versus time curve extrapolated to infinity, Day 1 to Day 7 of each period
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-25
Completion Date: 2019-04-22
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 8400001, Miami, Florida, 33014, United States
URL: https://clinicaltrials.gov/show/NCT03776227