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Clinical Trial Details

Trial ID: L2881
Source ID: NCT03310944
Associated Drug: Sotagliflozin (Sar439954)
Title: Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus
Interventions: DRUG: sotagliflozin (SAR439954)
Outcome Measures: Primary: Assessment of Pharmacokinetic (PK) Parameter: AUC, Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast), Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Maximum plasma concentration (Cmax), Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations, From 0 to 144 hours after IMP intake | Secondary: Assessment of PK Parameter: Tmax, Sotagliflozin: Time to reach maximum plasma concentration (Tmax), From 0 to 144 hours after investigational medicinal product (IMP) intake|Assessment of PK Parameter: Time to reach AUClast (Tlast), Sotagliflozin: Time to reach AUClast, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Terminal elimination half-life (t1/2), Sotagliflozin: Terminal elimination half-life (t1/2), From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Tmax, Sotagliflozin 3-O-glucuronide: Tmax, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Tlast, Sotagliflozin 3-O-glucuronide: Time to reach AUClast, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: t1/2, Sotagliflozin 3-O-glucuronide: t1/2, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: Cmax, Sotagliflozin 3-O-glucuronide: Cmax, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: AUC, Sotagliflozin 3-O-glucuronide: AUC, From 0 to 144 hours after IMP intake|Assessment of PK Parameter: AUClast, Sotagliflozin 3-O-glucuronide: AUClast, From 0 to 144 hours after IMP intake|Adverse Events, Number of patients with treatment emergent adverse events (serious and non-serious), Up to 75 days
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2017-10-18
Completion Date: 2017-12-08
Results First Posted:
Last Update Posted: 2022-04-13
Locations: Investigational Site Number 276001, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03310944