Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects

Sponsor
Sanofi
Study ID
NCT03310944
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Primary Objective: To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy subjects. Secondary Objectives: * To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and of the reference formulation in fasted conditions in healthy subjects. * To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in fasted conditions in healthy subjects.

Key Dates

Start date
Oct 18, 2017
Status verified
Apr 2022
Primary completion
Dec 8, 2017
Completion
Dec 8, 2017

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Sotagliflozin dose 1 (reference formulation)
    Single oral dose on Day 1 of one of the four period in fasting condition
  • Experimental: Sotagliflozin dose 2 (prototype p1 formulation)
    Single oral dose on Day 1 of one of the four period in fasting condition
  • Experimental: Sotagliflozin dose 3 (prototype p2 formulation)
    Single oral dose on Day 1 of one of the four period in fasting condition
  • Experimental: Sotagliflozin dose 4 (prototype p3 formulation)
    Single oral dose on Day 1 of one of the four period in fasting condition

Primary Outcome Measure

Assessment of Pharmacokinetic (PK) Parameter: AUC [ Time Frame: From 0 to 144 hours after IMP intake ]

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