A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

Part of paid clinical trials in Miami, Florida.

Sponsor
Sanofi
Study ID
NCT03776227
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 one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions * To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects

Key Dates

Start date
Jan 25, 2019
Status verified
Apr 2022
Primary completion
Apr 22, 2019
Completion
Apr 22, 2019

Study Design

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

Arms

  • Experimental: Sotagliflozin Test
    One tablet of sotagliflozin administered orally under fasting conditions
  • Active Comparator: Sotagliflozin Reference
    Two tablets of sotagliflozin administered orally under fasting conditions

Primary Outcome Measure

Cmax [ Time Frame: Day 1 of each period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8400001MiamiFlorida33014-

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