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A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03776227•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male or female subjects, between 18 and 55 years of age, inclusive.
•Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female.
•Body mass index between 18.0 and 30.0 kg/m2, inclusive.
•Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
•Normal vital signs after 10 minutes resting in supine position and after 3 minutes in standing position:
•* 95 mmHg \< systolic blood pressure (SBP) \<140 mmHg
•* 45 mmHg \< diastolic blood pressure (DBP) \<90 mmHg
•* 40 bpm \< heart rate (HR) \<100 bpm
•Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms\<PR\<220 ms, QRS\<120 ms, QTc≤430 ms if male, ≤450 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
•Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm.
+5 more criteria

Exclusion Criteria

•Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal (especially pancreatitis), hepatic (especially biliary disease, including cholecystectomy), renal, metabolic, hematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
•History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate (GFR) \<90 mL/min as calculated using the Cockcroft-Gault equation (7) at screening.
•Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
•Blood donation of a pint or more within 2 months before inclusion.
•Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
•Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
•History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
•Smoking more than 5 cigarettes or equivalent per day and/or unable to stop smoking during the study.
•Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
•If female, pregnancy (defined as positive human chorionic gonadotropin (β-HCG blood test), breast-feeding.
+12 more criteria

Locations (1)

Investigational Site Number 8400001

Miami, Florida, United States

Key Dates

Start Date

January 25, 2019

Primary Completion Date

April 22, 2019

Completion Date

April 22, 2019

Last Updated

April 25, 2022

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes MellitusHealthy Subjects

Interventions

sotagliflozin (SAR439954)

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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