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Clinical Trial Details

Trial ID: L3617
Source ID: NCT03211195
Associated Drug: Sotagliflozin (Sar439954)
Title: Sotagliflozin Bioequivalence Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)
Outcome Measures: Primary: Assessment of PK (pharmacokinetic) parameter: Cmax, Sotagliflozin: Maximum plasma concentration (Cmax), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: AUClast, Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: AUC, Sotagliflozin: Area under the concentration-time curve from 0 to infinity, From 0 to 120 hours after SAR439954 intake | Secondary: Assessment of PK parameter: Tmax, Sotagliflozin: Time to reach maximum plasma concentration (Tmax), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: t1/2, Sotagliflozin: Terminal elimination half life (T1/2), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: Vz/F, Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F, From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: CL/F, Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: Cmax, Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: AUC, Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity, From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: AUClast, Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: Tmax, Sotagliflozin 3-O-glucuronide: Time to reach maximum plasma concentration (Cmax), From 0 to 120 hours after SAR439954 intake|Assessment of PK parameter: t1/2, Sotagliflozin 3-O-glucuronide: Terminal elimination half life (T1/2), From 0 to 120 hours after SAR439954 intake|Treatment emergent adverse events (TEAE), Number treatment emergent adverse events, From 0 to 144 hours after SAR439954 intake
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-06-29
Completion Date: 2017-08-22
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 840001, Miami, Florida, 33014, United States
URL: https://clinicaltrials.gov/show/NCT03211195