Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03776227
Brief Summary:
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
Detailed Description:
Study duration per participant is approximately 103 days including a screening period up to 21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting 7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days after the last dose.
Study:
NCT03776227
Study Brief:
Protocol Section:
NCT03776227