Sotagliflozin Bioequivalence Study

Part of paid clinical trials in Miami, Florida.

Sponsor
Sanofi
Study ID
NCT03211195
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions. * To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.

Key Dates

Start date
Jun 29, 2017
Status verified
Apr 2022
Primary completion
Aug 22, 2017
Completion
Aug 22, 2017

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sotagliflozin - Commerical
    Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions
  • Active Comparator: Sotagliflozin -Development
    Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator

Primary Outcome Measure

Assessment of PK (pharmacokinetic) parameter: Cmax [ Time Frame: From 0 to 120 hours after SAR439954 intake ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840001MiamiFlorida33014-

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